Category Archives: Immunology

Seven million euros for research into chronic inflammatory bowel conditions

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

A new collaborative research centre/Transregio 241 ‘Immune-epithelial communication in inflammatory bowel diseases’ is due to commence its research at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) in July 2018.

In conjunction with the Charité hospital in Berlin, doctors and biotechnologists at FAU will be conducting research in order to better understand the interaction between cells in mucous membranes and immune cells in the bowel and to develop more effective therapy methods for chronic inflammation. The German Research Foundation (DFG) is providing funding worth 11.5 million euros for the first funding period until 2022, and FAU has been allocated nearly 7 million euros of this amount.

Number of patients with IBD is increasing

Severe diarrhoea, stomach pain, cramps – these are the most common symptoms of inflammatory bowel disease (IBD) such as Morbus Crohn or Colitis ulcerosa. Around 40,000 people in Germany suffer from IBD and this number continues to rise. Patients of IBD often suffer from flare-ups of their condition, which severely affects their quality of life and physical capabilities. ‘Despite the use of strong medication, chronic inflammatory bowel conditions remain difficult to treat’, says Prof. Dr. Christoph Becker, lead researcher at the Department of Medicine 1 at FAU’s Universitätsklinikum Erlangen and spokesperson of the collaborative research centre. ‘Acute flare-ups are often treated with corticosteroids that ease symptoms only in some cases. Many patients have to take several immunosuppressive substances.’ In addition, their symptoms are often accompanied by other conditions such as arthritis, acute inflammation of fatty tissue and chronic inflammation of the biliary tract in the liver.

Little research to date on molecular and cellular mechanisms

IBD is difficult to treat because the interactions between various cell populations in the bowel are not yet fully understood. ‘Newer findings show that the intestinal mucosa cannot be regarded as merely a physical barrier. In fact, it is highly-dynamic tissue that reacts to a large number of environmental stimuli including intestinal flora and local or systemic signals,’ explains Christoph Becker. ‘The immune system in the intestine regulates the barrier function of the intestinal wall and the composition of intestinal flora and vice versa as the intestinal barrier influences the immune system.’ However, there is a lack of knowledge of how the interactions between the epithelium and immune cells influence the long-term cellular reactions that contribute to controlling chronic inflammation processes.

New concept for new therapies

This is the starting point for the researchers from Erlangen and Berlin. During the next few years, they aim to integrate findings about the regulation and function of the immune system in the bowel and current data about anti-microbial defence on the mucous membrane barrier into a new concept. The individual projects will focus in particular on the role of misdirected communication between epithelium and immune cells during the pathogenesis of IBD. The researchers’ long-term aim is to develop medication that targets the causes of bowel inflammation while retaining the ability of the immune system to fight infections and cancer cells. In addition, they hope to find diagnostic methods that predict patients’ response to therapies – a goal that not only serves to relieve symptoms quickly, but should also contribute to lowering treatment costs.

Researchers from Erlangen involved in 14 projects

The scientific programme of CRC/TRR 241 is divided into three research areas: Area A ‘Immune regulation of intestinal barrier functions’, comprises projects focusing on the effects of acute and chronic inflammation on epithelial cells, in particular on their cell homeostasis and barrier-forming functions. Area B ‘The epithelium as a regulator of immunity and inflammation in the bowel’ examines the effects of disruptions to the barrier function and antigen translocation on the mucosal immune system. The objective of research area C ‘Diagnosis and therapeutic intervention of IBD’ is to develop innovative therapeutic and diagnostic approaches and evaluate them in a clinical setting. CRC/TRR 241 comprises a total of 22 projects, 14 of which are either based in Erlangen or involve researchers from Erlangen. The Department of Medicine 1 – Gastroenterology, Pneumology and Endocrinology, Department of Medicine 3 – Rheumatology and Immunology, the Department of Surgery and the Department of Dermatology and the Institute for Medical Biotechnology are all involved. 23 jobs and 9 scholarships are being funded during the next four years with the nearly 7 million euros allocated to the FAU.

SOURCE: www.eurekalert.org/pub_releases

Eczema drug effective against severe asthma

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Two new studies of patients with difficult-to-control asthma show that the eczema drug dupilumab alleviates asthma symptoms and improves patients’ ability to breathe better than standard therapies.

Two new studies of patients with difficult-to-control asthma show that the eczema drug dupilumab alleviates asthma symptoms and improves patients’ ability to breathe better than standard therapies. Dupilumab, an injectable anti-inflammatory drug, was approved in 2017 by the Food and Drug Administration as a treatment for eczema, a chronic skin disease.

The more than 2,000 patients enrolled in the studies suffered from moderate to severe asthma. All used standard asthma inhalers, and some also took oral steroids to control their severe asthma symptoms.

In one study, the rate of asthma exacerbations was almost cut in half for those taking dupilumab compared with those taking a placebo. On average, patients taking a placebo had close to one exacerbation per day during the year of the study. Exacerbations are periods of sudden worsening of asthma symptoms such as wheezing, coughing, shortness of breath and tightness in the chest.

Although the drug significantly reduced asthma symptoms for all patients, dupilumab worked particularly well in patients with high numbers of a specific type of white blood cell, called eosinophils, circulating in the bloodstream. For those patients, asthma exacerbations were cut by two-thirds.

“This drug not only reduced severe symptoms of asthma, it improved the ability to breathe,” said Dr Mario Castro, the Alan A. and Edith L. Wolff Distinguished Professor of Pulmonology and Critical Care Medicine. “That’s important because these patients have a chronic disabling disease that worsens over time with the loss of lung function. So far, we do not have a drug for asthma that changes the course of the disease. Current drugs for severe asthma help reduce trips to the emergency room, for example, but they don’t improve lung function.”

The first study included about 1,900 patients of at least 12 years of age and with moderate to severe asthma requiring they use at least three different inhalers to control their symptoms. One inhaler contained a corticosteroid that reduces inflammation, another contained a long-acting bronchodilator that relaxes airway muscles, and the third was a “rescue” inhaler filled with albuterol, a short-acting bronchodilator that quickly opens up the airway in the event of a more severe asthma attack.

Patients taking these inhaled medications then were randomly assigned to receive either dupilumab or a placebo for one year. Patients receiving dupilumab — an injectable antibody — also were randomly assigned to a higher or lower dose of the drug. Neither patients nor their doctors knew whether they were receiving the drug or the placebo.

In addition to reduced symptoms, the patients receiving dupilumab showed improved lung function in a test of “forced expiratory volume.” This test measures the amount of air a person can force from the lungs during a deep exhale. Patients receiving dupilumab, regardless of dose, improved their lung function by approximately 130-200 millilitres greater than those receiving the placebo. In general, there were no significant differences between the patients receiving high and low doses of dupilumab.

Rates of emergency room (ER) visits and hospitalisations also were improved for patients receiving the drug. In the placebo group (with 638 patients), on average, 6.5 percent of the patients required an emergency room visit or hospitalisation due to asthma during the study. In the dupilumab group (with 1,264 patients), on average, 3.5 percent of patients needed emergency care or hospitalisation due to asthma.

Based on the second study, Dr Castro said another benefit of the drug could be the ability to wean severe asthma patients off of chronic oral steroids, which can cause debilitating long-term side effects, including stunted growth, diabetes, cataracts and osteoporosis. The second study included about 200 patients using the same inhaled asthma medications as patients in the larger trial, plus additional oral steroids — usually prednisone — to control their more severe symptoms. Half of the patients receiving dupilumab in this study were able to completely eliminate prednisone use. And 80 percent of dupilumab-treated patients were able to at least cut their doses in half. Patients on placebo also reduced prednisone use but to a lesser degree, likely because the protocols of participating in a clinical trial help asthma control generally.

Dr Castro said doctors would like to help patients rely less on steroids for asthma control because those with severe asthma can be forced to take these drugs for decades to enable them to breathe.

“I have patients who have had to stop working and go on disability because their asthma symptoms are so severe they can no longer function in the workplace,” Dr Castro said. “I’m excited about the potential of dupilumab because I have so many patients who have maxed out on available therapies and they still can’t breathe. It can become a very disabling disease.”

Patients receiving dupilumab did experience known side effects of the drug, including pain and swelling at the injection site and a short-term bump in the number of eosinophil cells in the blood. Five patients who received dupilumab and three patients who received placebo died during the study period. According to the investigators and descriptions of these patients’ medical histories, all suffered from multiple severe medical conditions, and none of the deaths was deemed related to the study protocol.

The studies will be published online in The New England Journal of Medicine.

SOURCE: www.europeanpharmaceuticalreview.com/news/75890

Ipsen receives European first-line approval for Cabometyx

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Ipsen has revealed that it has received approval for the use of Cabometyx for first-line use in patients with advanced renal cell carcinoma (RCC).

The approval builds on the second line approval it had previously received in 2016, although negotiations with numerous European countries over the price of medicine have delayed access for many nations until recently.

NICE gave approval for the use of the treatment in July 2017, close to a year after its EC approval.

Though sales so far have not been blistering, recording European sales of only £25 million in the first quarter, it is expected that this first-line approval and with numerous funding agreements falling into place with payers that the drug sales will grow quickly.

Part of the reason for this is the advantage it holds over a main competitor, in BMS’ Opdivo; Cabometyx is differentiated by being available in oral form, which makes it far more convenient than having to visit a hospital for IV infusion.

“Today’s EC approval is a step forward for advanced kidney cancer patients in Europe who will be able to access a new oral first-line treatment option that offers significant improvement over the standard of care”, said Harout Semerjian, Executive Vice President, Chief Commercial Officer, Ipsen.  “Ipsen remains committed to improving patients’ lives by continuing to develop new therapies and expanding the potential of Cabometyx across different indications.”

The approval is based on results from a Phase 3 trial that hit primary endpoint of extending progression-free survival (PFS). The data revealed that PFS was improved by 8.6 months, compared with 5.3 months of patients taking Pfizer’s Sutent. In terms of overall survival (OS), the company reported that it showed a favourable, though not statistically significant, trend – as OS with Cabometyx stood at 26.6 months against 21.2 months on Sutent.

In terms of further development, Ipsen is developing the treatment as an adjunct alongside immunotherapy.

SOURCE: www.pharmafile.com/news/517387

Initiative launched to improve people’s understanding of eczema

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

A scheme to raise awareness about the emotional and physical impact of the most common type of eczema has been launched by a leading charity and a global biopharmaceutical company this month.

Scratch Beneath the Surfaceis a public health initiative established by Sanofi in collaboration with Allergy UK. The scheme aims to improve people’s understanding of atopic dermatitis, from what’s happening inside the body, to the emotional and psychological symptoms that can lie beneath the surface.

The condition affects over 1.5 million people in the UK,1,2 and in a survey, 80% reported that it impacted on their mood, mental health and well-being.

By improving awareness of atopic dermatitis, which is the most common type of eczema3 the initiative aims “to shift any misconceptions among the general public and combat the stigma related to the disease, which will in turn, lead to those affected feeling a greater sense of support and understanding”, Sanofi said.

Commenting on the launch of the initiative, Carla Jones, Allergy UK’s chief executive said: “Atopic dermatitis is often dismissed as a simple skin condition or rash that can be soothed with moisturisers, but people don’t realise that it’s a long-term and potentially life-altering disease.”

“There is a huge sense of frustration amongst those affected, who feel that eczema and atopic dermatitis are often misunderstood. Even simple day-to-day tasks like walking up the stairs, bathing and getting dressed can be painful for someone experiencing a flare-up,” she said.

A UK-wide survey of people with moderate-to-severe atopic dermatitis4found that the disease can impact every aspect of an individual’s life. Difficulty sleeping emerged as a significant problem, affecting 75% of those surveyed; with the constant itching and pain when trying to sleep, leaving people feeling tired and restless in the day.4

For some people, the impact of unpredictable flare-ups and feelings of self-consciousness can also lead to symptoms of anxiety or depression.4

Some 80% of survey participants reported that atopic dermatitis has a direct impact on their mood. In interviews, participants reported feeling anxious, especially in public and social settings, and feeling that they’re being looked at and judged by others.4

57% admitted they feel depressed because of their skin with some taking antidepressants to try and help the situation.4 And 60% of male participants and 55% of female participants noted that their self-esteem and self-confidence is frequently impacted due to their skin condition.

Commenting on the findings, Dr Anthony Bewley, consultant dermatologist at Whipps Cross University Hospital, and the Royal London Hospital, said: “Despite affecting over one and a half million adults in the UK, too few people understand the inflammatory and unpredictable nature of atopic dermatitis.

“For many people, it’s the unseen consequences, the emotional and psychological impact hiding beneath the surface that makes the disease most difficult to live with. Itchy skin is considered to be one of the worst symptoms; it can be physically debilitating.

“However, the associated restlessness, sleepless nights, and sore, broken skin can have a severe impact on a person’s daily functioning, mental health and self-esteem,”  he said.

References

  1. Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66 (suppl 1): 8-16.
  2. Office for National Statistics. 2014 UK mid-year population estimate. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationprojections/bulletins/nationalpopulationprojections/2015-10-29 (Accessed April 2018).
  3. NHS Choices. Atopic Eczema (Atopic Dermatitis). Available at: https://www.nhs.uk/conditions/atopic-eczema/  (Accessed April 2018).
  4. Sanofi data on file, March 2018.

SOURCE: www.hospitalpharmacyeurope.com/editors-pick

Experimental vaccine to be used against Ebola outbreak in the DRC

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

campaign to vaccinate people at risk of developing Ebola in the latest outbreak in the Democratic Republic of the Congo could begin by the end of this week, Tedros Adhanom Ghebreyesus, the director-general of the World Health Organization, said Sunday.

Tedros said the government of the DRC has formally asked to use an experimental vaccine being developed by Merck. The WHO has a stockpile of 4,300 doses of the vaccine in Geneva; the company also has 300,000 doses of the vaccine stockpiled in the United States. Merck has given its permission for the vaccine to be used in this outbreak.

“Everything is ready for the vaccine. They want it,”  Tedros, who goes by his first name, told STAT in an interview from Kinshasa.

The WHO and its partners are responding quickly, concerned that this outbreak has the potential to spread because of its location. The epicenter, a town called Bikoro, is difficult to reach by vehicle because of poor roads between it and the regional capital, Mbandaka. Tedros and his party traveled there by helicopter.

But the town is a port, on Lake Tumba. And it feeds into the Congo and Ubangi rivers — major waterways that connect to several large centers.

To the south is the DRC capital, Kinshasa (population 11.5 million), as well as Brazzaville (population 1.9 million), the capital of the neighboring Republic of the Congo. To the north is Bangui (population 800,000), the capital of the Central African Republic. Mbandaka, with a population of about 1 million people, is also reachable from Bikoro by water.

The World Food Program has established an air bridge, a costly undertaking but one that is essential for moving people and materiel into Bikoro.

The equipment needed to keep the vaccine at subzero temperatures — the so-called cold chain — was arriving in the DRC on Sunday and would be set up in the next couple of days, he said. By Wednesday or Thursday, the vaccines in Geneva will be sent to the DRC, said Tedros. After that, vaccination of health care workers and people who have been in contact with cases will begin.

“That’s our plan. And so far things are going as planned,” he said, expressing hope that the quick response will speed containment of the outbreak. “We have better weapons this time.”

The outbreak, which is believed to have started at least five weeks ago, was officially declared on May 8 after the DRC health ministry confirmed two positive tests from among a number of suspected Ebola cases in Bikoro and a village called Ikoko-Impenge, about 40 miles away.

The WHO said on Saturday the case estimate is up to 39 — two confirmed, 20 probable cases, and 17 suspected. At least 18 of those people have died. Three health care workers are among the cases and one has died.

The plan is to employ a ring vaccination approach, vaccinating anyone who has been in contact with a case to prevent continuing spread of the virus. Contact tracing efforts are already underway. To date, 382 contacts have been identified, Tedros said.

SOURCE: www.statnews.com

Emergex wins Innovate UK grant to advance universal flu vaccine

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

A UK biotech developing a pioneering a new approach to developing vaccines for infectious diseases has been awarded a grant of £979,318 by Innovate UK.

Emergex Vaccines says the funds will help fuel progress of its universal flu vaccine programme through preclinical development.

The vaccine is designed to target components of the influenza virus that are common to all strains, and will therefore also be suitable to target the outbreak of a new flu pandemic caused by the emergence of a novel form of the virus at the time it moves from an animal species into humans, according to the firm.

The vaccine is 100 percent synthetic and delivers “highly conserved immunogenic peptide fragments from the flu virus to antigen presenting cells in the skin, eliciting a strong and long-lasting T-cell immune response,” it said.

The grant should cover 70 percent of the cost of developing the flu vaccine programme over a period of two years, and will be used to complete preclinical toxicology and validation studies and the manufacturing of the vaccine, so that clinical batches are ready for Phase I clinical testing in the first half of 2020.

“This Innovate UK grant provides endorsement of our flu vaccine programme and reinforces our belief that an innovative approach, using the very latest technologies, could help protect the public from this inevitable epidemic or pandemic health threat,” noted Professor Thomas Rademacher, co-founder, chief executive and chief scientific officer at Emergex.

SOURCE: www.pharmatimes.com/news

FDA approves new drug to treat MS in pediatric patients

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients.

“For the first time, we have an FDA-approved treatment specifically for children and adolescents with multiple sclerosis,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can have a profound impact on a child’s life. This approval represents an important and needed advance in the care of pediatric patients with multiple sclerosis.”

Gilenya was first approved by the FDA in 2010 to treat adults with relapsing MS.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function and appearance of new symptoms, called relapses or flare-ups, are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to progressive decline in function and increased disability. Most people with MS experience their first symptoms, like vision problems or muscle weakness, between the ages of 20 to 40. Two to five percent of people with MS have symptom onset before age 18 and estimates suggest that 8,000 to 10,000 children and adolescents in the U.S. have MS.

The clinical trial evaluating the effectiveness of Gilenya in treating pediatric patients with MS included 214 evaluated patients aged 10 to 17 and compared Gilenya to another MS drug, interferon beta-1a. In the study, 86 percent of patients receiving Gilenya remained relapse-free after 24 months of treatment, compared to 46 percent of those receiving interferon beta-1a.

The side effects of Gilenya in pediatric trial participants were similar to those seen in adults. The most common side effects were headache, liver enzyme elevation, diarrhea, cough, flu, sinusitis, back pain, abdominal pain and pain in extremities.

Gilenya must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. Serious risks include slowing of the heart rate, especially after the first dose. Gilenya may increase the risk of serious infections. Patients should be monitored for infection during treatment and for two months after discontinuation of treatment. A rare brain infection that usually leads to death or severe disability, called progressive multifocal leukoencephalopathy (PML) has been reported in patients being treated with Gilenya. PML cases usually occur in patients with weakened immune systems. Gilenya can cause vision problems. Gilenya may increase the risk for swelling and narrowing of the blood vessels in the brain (posterior reversible encephalopathy syndrome). Other serious risks include respiratory problems, liver injury, increased blood pressure and skin cancer. Gilenya can cause harm to a developing fetus; women of child-bearing age should be advised of the potential risk to the fetus and to use effective contraception.

The FDA granted Priority Review and Breakthrough Therapy designation for this indication.

The FDA granted the approval of Gilenya to Novartis.

SOURCE: www.news-medical.net/news/20180514

Medigene in for up to $1.5 billion under broader pact with Bluebird Bio

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

German biotech firm Medigene has secured a wider remit under a collaboration with U.S. peer Bluebird Bio on a technology that boosts the immune response to cancer, increasing the pool of potential milestone payments to $1.5 billion.

The number of projects in the alliance, which has Medigene contributing screening tools to identify promising T-cell receptors (TCR), will rise from four to six, Medigene said in a statement on Monday, sending its shares 8 percent higher.

“If successfully developed and marketed through several indications and markets, Medigene could receive up to $250 million in milestone payments per TCR program in addition to tiered royalty payments on net sales up to a double-digit percentage,” Medigene said.

Medigene agreed its alliance with Bluebird in September 2016, working on modified T cells, one of the immune system’s main weapons, to better target specific tumor cells.

The extended collaboration contract validates Medigene’s technology platform, analysts at Baader Helvea said, confirming their “buy” recommendation.

Bluebird is best known for its progress in a class of customized cancer drugs known as chimeric antigen receptor T-cells, or CAR-Ts.

Other companies working on T cell receptor (TCR) technologies include GlaxoSmithKline, Britain’s Immunocore, which is backed by the Bill & Melinda Gates Foundation, or U.S. biotech group ImmunoCellular .

As part of the broadened contract, Medigene will receive an additional one-time payment of $8 million plus increased research and development funding.

SOURCE: www.uk.reuters.com/article

In Europe, Mylan’s rivals try to plug EpiPen shortages

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

LONDON (Reuters) – European makers of emergency allergy treatments are stepping up production of alternative life-saving adrenaline shots to try to fill intermittent shortages of Mylan’s (MYL.O) market-leading EpiPen injection.

Mylan began warning about EpiPen supply constraints in Britain two months ago. Canada has also seen similar problems, while on Wednesday the Food and Drug Administration added EpiPens to its list of drugs in shortage in the United States.

The shortfall reflects manufacturing delays at Pfizer’s (PFE.N) Meridian Medical Technologies unit, which is Mylan’s manufacturing partner and produces all the EpiPens sold globally at a single plant near St. Louis.

Allergy charities said there were anecdotal reports of some patients having difficulty filling prescriptions but there did not appear to be major supply issues overall, thanks to the availability of rival products.

Jext and Emerade, from ALK-Abello (ALKb.CO) and Valeant’s (VRX.TO) Bausch+Lomb unit respectively, are sold in both Britain and parts of Europe, while Lincoln Medical makes Anapen for certain European markets outside the UK.

“ALK has increased its production,” a spokesman for Denmark-based ALK-Abello said on Thursday. “We are doing all we can to meet the increased demand. We can make up some of the shortfall but not all, as EpiPen has a market share of around 70 percent.”

Lincoln Medical said it had not yet seen any major impact in Europe, reflecting the fact that the market was cushioned by multiple sources of supply and by the stocks held at distributors.

A spokeswoman for Britain’s health department said “limited” supplies of standard-dose EpiPens were available and stocks were being closely managed to ensure pharmacies could fulfil prescriptions. Supplies of half-dose 0.15 mg EpiPen junior have not been hit and remain readily available.

“Any patient who is unable to obtain supplies of EpiPen 0.3 mg should speak to their doctor about using an alternative,” she said.

EpiPens and other competing devices deliver doses of adrenaline via an automatic injector that a patient or caregiver can administer in the event of severe allergic reaction, such as to bee stings or exposure to peanuts.

SOURCE: www.uk.reuters.com/article

AZ’s Fasenra stumbles in P3 for COPD

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

AstraZeneca’s Fasenra arrived later on the scene than GSK rival med, Nucala, and so it needed to quickly rack up indications to mount a serious challenge – in COPD, at least, that looks more unlikely after the treatment wasn’t able to meet its primary endpoints in a Phase 3 trial.

Fasenra is already approved to treat severe eosinophilic asthma in major markets around the world but was hoping to add to this with an expansion into treating exacerbations in those with moderate to very severe COPD.

Had it succeeded to hit its endpoints, it would have joined GSK in submitting for regulatory approval but now looks set to fall behind, should its rival receive approval.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “COPD is a debilitating disease with significant unmet need among patients whose disease remains uncontrolled despite treatment with existing inhaled therapies. We will now await the results of Terranova and a full evaluation of both trials to determine next steps for Fasenra in COPD.”

GSK did not have a smooth path to acquire the data needed it to submit for approval; in its Metreo study, the drug demonstrated a reduction in exacerbations but not to a level that were statistically significant.

However, it managed to scrape successful results in another trial that was on-going concurrently (Metrex) in reducing exacerbations. It shows that these types of monoclonal antibody treatments can be hit-and-miss in trials for COPD.

Full details were not revealed by AstraZeneca about how far its drug missed the mark but, as mentioned by Bohen, the company has another trial running. If this trial succeeds and the drug only just missed the mark, it could still be emboldened to attempt to file for approval – in a similar manner to GSK.

Fasenra entered the market two years after Nucala but has some advantages that could see it leech GSK’s sales in the area; the product is administered by subcutaneous injection but is delivered every eight weeks (compared to four weeks for Nucala), after a lead-in dosing schedule and is priced at a lower level.

SOURCE: www.pharmafile.com/news/517342