Category Archives: Haematology

AbbVie trial backs chemo-free Imbruvica combo regimen

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The pairing of of AbbVie’s Imbruvica and Roche’s Gazyva has hit the mark in a chronic lymphocytic leukaemia trial – raising the prospect of a new chemotherapy-free combination regimen for previously untreated CLL patients.

The iLLUMINATE trial showed that oral BTK inhibitor Imbruvica (ibrutinib) plus anti-CD20 injection Gazyva (obinutuzumab) was more effective than Gazyva plus chemo (chlorambucil) in treatment-naïve, older patents (aged 65 or more) with either CLL or small lymphocytic leukaemia (SLL) – a different form of the same disease.

The top-line data isn’t being made available just yet, but in a statement AbbVie said the duo extended progression-free survival (PFS) compared to the active control arm, adding that it will be sharing the data with regulators, in the hope of bringing “the first chemotherapy-free CD20 combination in first-line CLL treatment” to market.

The trial ties in with AbbVie’s strategy of expanding use of Imbruvica as a first-line CLL treatment and, while Gazyva has been something of a slow burner for Roche since its launch in that setting in 2014, it has started to gain momentum with sales rising 41% to CHF 278m last year.

The combination of Gazyva and chlorambucil is now recommended as a first-line therapy for CLL by the US National Comprehensive Cancer Network, which deems it a category 1 treatment, ie one with a high level of evidence backing its use, so outperforming it is a big win for the combination.

“This chemotherapy-free combination represents a potential new treatment option for patients with CLL,” said John Gribben of Barts Cancer Institute in the UK, the lead investigator for the iLLUMINATE study.

“It’s exciting to see the blood cancer treatment paradigm continue to evolve – each advance moves us one step closer to a better standard of care for these patients,” he added.

Imbruvica is already approved for all lines of therapy in CLL, and beating out chlorambucil is not a big surprise as AbbVie’s drug comprehensively outperformed the chemotherapy as a monotherapy in the head-to-head RESONATE-2 trial.

The trial was the basis of Imbruvica’s approval in 2016 as a chemo alternative in treatment-naïve CLL, and the disease accounts for the lion’s share of the drug’s sales, which grew almost 39% to $762m in the first quarter of this year, topping estimates. AbbVie is predicting sales of $3.3bn this year, well on course for its peak sales target of $6bn-$7bn.

AbbVie’s head of R&D Michael Severino said on the company’s first-quarter results call that the strategy is to build a “body of evidence” for Imbruvica – both as a monotherapy and in combination – across different CLL segments “including young and fit patients and the watch-and-wait population”.

SOURCE: www.pmlive.com/pharma_news

Eczema drug effective against severe asthma

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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

GSK’s blockbuster HIV drug linked with birth defects

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Regulators in Europe and the US have issued warnings about a link between GlaxoSmithKline’s blockbuster HIV drug Tivicay (dolutegravir) and birth defects of the brain and spine.

The European Medicines Agency’s safety committee has said it is evaluating preliminary results from a study which found four cases of birth defects such as spina bifida – a malformed spinal cord – in babies born to mothers who became pregnant while taking Tivicay (dolutegravir).

The Pharmacovigilance Risk Assessment Committee (PRAC) has issued precautionary advice while assessing the study, saying Tivicay should not be prescribed to women seeking to become pregnant.

Women who can become pregnant should use effective contraception while taking Tivicay-based medicines, the PRAC said.

In a separate announcement the FDA said it was also issuing a warning following preliminary results of an ongoing observational study in Botswana, suggesting women who took Tivicay at the time of becoming pregnant, or early in the first trimester, appear to be at higher risk for these birth defects.

The US regulator warned against stopping Tivicay-containing regiments without first switching to alternative HIV medicines, as this could cause the virus to spread to the unborn baby.

Women of childbearing age should talk to healthcare professionals about other non-Tivicay containing medicines.

Tivicay, an integrase strand transfer inhibitor (INSTI) is an important drug for GlaxoSmithKline, which produces the drug through its ViiV joint HIV venture with Pfizer and Shionogi.

Tivicay (dolutegravir) is sold on its own for use as a component of combinations involving other drugs, and generated sales of £1.4 billion,

And Triumeq, which combines dolutegravir with nucleoside reverse transcriptase inhibitors abacavir and lamivudine, brings in sales of more than £2.4 billion.

There are alternatives from the same class such as Merck & Co’s Isentress (raltegravir) and combinations, and combinations containing Gilead’s elvitegravir.

These are still preliminary findings, and the warnings have been issued purely as a precaution.

But preventing HIV spreading to unborn children is important to the medical community, and if there is stronger evidence of a link with birth defects, doctors will surely look for alternative therapies.

SOURCE: www.pharmaphorum.com/news

AZ’s potassium drug Lokelma finally approved in US

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AstraZeneca badly needs new drugs on the market as several former blockbusters have been hit by generic competition – and finally its high potassium treatment Lokelma has been approved by US regulators.

The drug, a highly selective potassium-removing agent, has been approved at the third time of asking by the FDA, which had been concerned about issues at its manufacturing plant in Texas.

European regulators approved the drug formerly known as ZS-9 in March after their concerns over the issues were resolved, and after two previous rejections the US regulator is also satisfied with the technical arrangements at the facility.

AZ gained rights to the drug after buying ZS Pharma in 2015 for $2.7 billion and is designed to treat hyperkalaemia, where high potassium levels threaten kidney and heart function.

Lokelma (sodium zirconium cyclosilicate) will compete with Vifor Pharma group member Relypsa’s rival Veltassa (patiromer), which has been on the market for a few years in the US and Europe.

The Anglo-Swedish pharma has predicted sales in excess of $1 billion annually for ZS-9, although some analysts say this is a conservative estimate.

The risk of hyperkalaemia increases significantly for patients with chronic kidney disease (CKD) and for those who take common medications for heart failure (HF), such as renin-angiotensin-aldosterone system (RAAS) inhibitors, which can increase potassium in the blood.

To help prevent the recurrence of hyperkalaemia, RAAS-inhibitor therapy is often modified or discontinued, which can compromise cardio-renal outcomes and increase the risk of death.

Sean Bohen, chief medical officer at AstraZeneca, said: “The consequences of hyperkalaemia can be very serious and it’s reassuring for treating physicians that Lokelma has demonstrated lowering of potassium levels in patients with chronic kidney disease, heart failure, diabetes and those taking RAAS inhibitors.”

AZ badly needs the new sales – sales of its Crestor (rosuvastatin), a former blockbuster were down 38% in Q1, to $338 million, and overall revenues fell 4% to just under $5.2 billion.

The company is selling off its old and unwanted drugs to prop up revenues and reduce costs – but this can only be seen as a short-term measure before new revenues come on stream.

CEO Pascal Soriot also faces a shareholder revolt, after more than 37% of shareholders voted against or abstained at the firm’s annual meeting when asked to approve a £9.4m pay package for Soriot, down from £14.3 million last year.

Soriot has set a sales target of above $40 billion by 2023, despite the struggles getting new drugs to the market.

SOURCE: www.pharmaphorum.com/news

Celebrating 15 years of life-saving technology

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The experts in temperature controlled packaging Peli BioThermal, are celebrating 15 years of the Original Golden Hour container, developed to provide blood to critically wounded soldiers.

The award-winning Original Golden Hour container – the company’s flagship product – was recognised in 2003 as part of the US Army’s Greatest Inventions programme, has gone on to shape future product development, influencing the full range of Peli BioThermal reusable and single-use products.

“We developed the Original Golden Hour to address a critical need facing our military personnel — how to make blood available to treat the critically wounded within the crucial first hour after injury,” explained Kevin Lawler, Peli BioThermal VP of sales, “Today, the technology behind this product allows us to provide reliable temperature control not only for blood on the battlefield, but also for life-saving civilian applications, including the transport of biologics and temperature sensitive pharmaceuticals for clinical trials and commercial distribution.”

The technology is incorporated in a range of Peli BioThermal products, which are utilised by emergency first responders globally.

In 2003, the US Army needed a way to store blood and platelets to aid emergency medics saving lives on the battlefield. The answer, The Original Golden Hour container was the answer to a proposal from the US Army in 2003, when they needed a way to store blood and platelets to aid emergency medics saving lives on the battlefield. The container was subsequently included as part of the 2003 US Army’s Greatest Inventions program by the US Army Research, Development and Engineering Command (RDECOM) Public Affairs office.

“If you can make sure that someone doesn’t bleed out by giving a resupply of blood right there, you’ve exponentially impacted the ability to save that soldier’s life,” said sixteenth chairman of the joint chiefs of staff, retired US Marine general, Peter Pace, who also serves as chairman of the board for Pelican Products.

It truly makes a difference on the battlefield. And that’s as true today as it was 15 years ago.”

Patented Golden Hour Technology provides superior thermal protection for high value temperature-sensitive payloads between 2 and 1686 liters, from -50ºC to 25°C for up to seven days (168 hours). Today, Golden Hour Technology is integral to all of the company’s products, including reusable products like the Credo Cube shipper and the Credo ProMed series, as well as the Chronos range of single-use shippers.

SOURCE: www.manufacturingchemist.com/news

Three medicines step closer to EU approval

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Three medicines treating HIV, pain and cancer have been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) at its latest meeting.

Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) was endorsed as a treatment HIV-1 infection.

The once-daily single tablet regimen has shown high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase III clinical trials involving treatment-naïve adult patients and among virologically suppressed adults who switched regimens.

The marketing application contains data from four Phase III studies in which the regimen met its primary goal of non-inferiority to ViiV Healthcare’s flagship drug dolutegravir (DTG) at 48 weeks.

The therapy was approved in the US in February.

The CHMP also recommended approval of one hybrid medicine, FGK Representative Service GmbH’s Dzuveo (sufentanil), for the treatment of pain.

Hybrid applications rely in part on the results of preclinical tests and clinical trials for a reference product and in part on new data.

The opioid produces analgesia by activating μ-opioid receptors primarily within the central nervous system, and its most common side effects are nausea, vomiting and pyrexia.

Elsewhere, the Committee voiced its support for Obvius Investment BV’s generic medicine Carmustine Obvius (carmustine), for the treatment brain tumours, non-Hodgkin’s lymphoma and Hodgkin’s disease.

SOURCE: www.pharmatimes.com/news

Stroke prevention drugs may help reduce dementia risk for atrial fibrillation patients

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Patients with atrial fibrillation could reduce the risk of dementia by taking stroke prevention medications, according to recommendations published online in EP Europace, a European Society of Cardiology journal, and presented at EHRA 2018.

The international consensus document was also published in HeartRhythm, the official journal of the Heart Rhythm Society (HRS), and Journal of Arrhythmia, the official journal of the Japanese Heart Rhythm Society (JHRS) and the Asia Pacific Heart Rhythm Society (APHRS).

The expert consensus statement on arrhythmias and cognitive function was developed by the EHRA, a branch of the ESC; the HRS; the APHRS; and the Latin American Heart Rhythm Society (LAHRS).

Heart rhythm disorders (arrhythmias), as well as some procedures undertaken to treat them, can increase the risk of cognitive decline and dementia. The international consensus document was written for doctors specialising in arrhythmias and aims to raise awareness of the risks of cognitive impairment and dementia and how to reduce them.

The document states that atrial fibrillation is associated with a higher risk for cognitive impairment and dementia, even in the absence of apparent stroke. This may be because atrial fibrillation is linked with a more than two-fold risk of silent strokes. The accumulation of silent strokes and the associated brain injuries over time may contribute to cognitive impairment.

Stroke prevention with oral anticoagulant drugs is the main priority in the management of patients with atrial fibrillation. The consensus document says that oral anticoagulation may reduce the risk of dementia.

Adopting a healthy lifestyle may also reduce the risk of cognitive decline in patients with atrial fibrillation. This includes not smoking and preventing or controlling hypertension, obesity, diabetes, and sleep apnoea.

“Patients with atrial fibrillation may be able to reduce their risk of cognitive impairment and dementia by taking their oral anticoagulation medication and having a healthy lifestyle,” said Dr Nikolaos Dagres, lead author and consultant, Department of Electrophysiology, Heart Centre Leipzig, Germany.

The document also reviews the association between other arrhythmias and cognitive dysfunction, including post-cardiac arrest, in patients with cardiac implantable devices such as implantable cardioverter defibrillators (ICDs) and pacemakers, and ablation procedures.

Treatment of atrial fibrillation with catheter ablation can itself lead to silent strokes and cognitive impairment. To reduce the risk, physicians should follow recommendations for performing ablation and for the management of patients before and after the procedure.

The consensus document notes that physicians may suspect cognitive impairment if a patient’s appearance or behaviour changes — for example, if appointments are missed. Family members should be asked for collateral information. If suspicions are confirmed, the consensus document recommends tools to conduct an objective assessment of cognitive function.

The paper highlights gaps in knowledge and areas for further research. These include, for instance, how to identify atrial fibrillation patients at increased risk of cognitive impairment and dementia, the effect of rhythm control on cognitive function, and the impact of cardiac resynchronisation therapy (CRT) on cognitive function.

SOURCE: www.hospitalhealthcare.com/editors-pick

How thalidomide is effective against cerebral infarction

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Scientists reveal that this dangerous drug could suppress nerve cell death.

Notoriously remembered as a major pharmaceutical scandal approximately 60 years ago, thalidomide caused severe birth defects when many pregnant women took the drug as a remedy for their morning sickness.

In recent years, however, thalidomide and its derivatives have been widely used to treat haematologic malignancies such as multiple myeloma.

Evidence also suggests that thalidomide has a neuroprotective effect, reducing both oxidative stress and inflammatory response, but the exact molecular mechanisms of thalidomide on the brain were unknown.

To investigate, scientists at Waseda University and Tokyo University of Pharmacy and Life Sciences studied thalidomide’s target protein, cereblon (CRBN), and its binding protein, AMP-activated protein kinase (AMPK), which plays an important role in maintaining intracellular energy homeostasis in the brain.

Through their study, they revealed that thalidomide inhibits the activity of AMPK via CRBN under oxidative stress and suppresses nerve cell death.

“We hope that our findings will help with the development of new and safer thalidomide derivatives,” says Naoya Sawamura, Associate Professor of Neuropharmacology at Waseda University and leading author of this study, “to better treat diseases such as cerebral infarction, a type of stroke, which is a major cause of death worldwide.”

Specifically, Sawamura’s research group used cerebral ischaemia model rats of the cerebral artery occlusion/reperfusion (MCAO/R) to examine the effect of thalidomide on infarct lesions caused by cerebral ischaemia and related intracellular signals.

After performing qualitative analysis and assessments on the rats’ physical movements, they found that thalidomide treatment significantly decreased the infarct volume and neurological deficits in MCAO/R model rats, and that AMPK was the key signalling protein in the mechanism through additional experiments.

Moreover, to determine the molecular mechanisms of the effect of thalidomide on neuronal death, they used oxidative stress-induced neuronal cells, which were induced by administration of H2O2, as cerebral ischaemia model cells.

“In these cells, we found that the AMPK-CRBN interaction weakened and phosphorylation of AMPK enhanced, but thalidomide treatment restored the AMPK-CRBN interaction and suppressed phosphorylation of AMPK,” explains Sawamura.

“What this implies is that thalidomide regulates AMPK-CRBN interactions in cells under ischaemic conditions, meaning, it can suppress nerve cell death.”

Further study is needed to identify effective thalidomide derivatives with fewer side-effects, as well as more stability because they undergo hydrolysis spontaneously and rapidly in aqueous solutions.

Nevertheless, Sawamura is excited about the future possibilities of this study.

“Our attention is now on the functions of CRBN as a stress response molecule. The suppression of nerve cell death by thalidomide perhaps occurs because CRBN’s function as a stress molecule is somehow enhanced.”

“We want to elucidate the response of cereblons in ageing and stress models to see if decline in the CRBN function could be a biomarker for ageing and stress.”

SOURCE: www.manufacturingchemist.com/news

Magnetic nanoparticles prevent internal bleeding

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Scientists have found a way to effectively stop internal bleeding by magnetically-driven nanoparticles containing thrombin.

Scientists have found a way to effectively stop internal bleeding by magnetically-driven nanoparticles containing thrombin. A drug based on these nanoparticles can be injected intravenously and delivered straight to the site of a vascular injury. It can accelerate local clot formation and reduce overall blood loss by 15 times. The nanoparticles are not toxic to humans and can potentially be used for safe treatment.

In a new study, scientists from ITMO University suggested using magnet-driven nanoparticles to solve this problem. The particles consist of two key components. The first is thrombin, an enzyme responsible for blood clotting. It interacts with the protein called fibrinogen and triggers clot formation in order to block the damaged vessel. The thrombin is wrapped into a special porous matrix made of magnetite. This mineral is the second main ingredient and allows for precise control of the movement of particles inside the body using an external magnetic field.

Magnetic nanoparticles with thrombin have low activity and do not cause blood clotting if they are evenly distributed in blood vessels. Therefore it is possible to inject a solution of particles intravenously and localise them where needed using a magnet. When the patient receives an extra portion of fibrinogen, thrombin particles around the site of injury interact with it and the bleeding stops faster.

“We tested the nanoparticles’ efficiency on human blood plasma samples and a special vessel model,” says Andrey Drozdov, member of SCAMT Laboratory at ITMO University. “After the first experiments with plasma, we found out that thrombin in our nanoparticles is less active compared to its free variant. Yet we went on with the tests and ran additional experiments on a model of the bloodstream. We were able to observe how nanoparticles behave when the vessel is damaged. It turned out that magnetic localisation compensates for lower activity. Nanoparticles reduce the clotting time by 6.5 times and can reduce total blood loss by 15 times.”

“Synthesising these nanoparticles is not easy,” said the head of the laboratory Vladimir Vinogradov. “It is important to keep their size down to 200 nanometers; otherwise they will not be suitable for injection. In addition, mild synthesis conditions are required so that the thrombin molecule does not break down and lose its activity completely. Finally, we could only use biocompatible components. We checked the toxicity of our particles with human cells and made sure they are completely safe even during prolonged exposure.”

This work is part of a larger project aiming to create hybrid nanomaterial-based hemostatic drugs. Scientists are currently planning to test the drug based on the obtained material on animal models and, in case of success, run clinical trials. Researchers hope to create a nanoparticle-based hemostasis system that will be able to quickly and efficiently stop internal bleeding.

The results were published in Scientific Reports.

SOURCE: www.europeanpharmaceuticalreview.com/news/73444

Diabetes tablet passes Phase III clinical trial

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As rates of diabetes continue to rise, the hunt for new drugs to tackle the metabolic disease is imperative.

In 2014 there were an estimated 422 million people with diabetes, compared to just 108 million in 1980.

Although there are a range of treatment options available for type 2 diabetes, many target the symptoms rather than the root cause and may have adverse side effects. A further difficulty is the close connection between diabetes and obesity, which is causing cases to increase.

Novo Nordisk’s semaglutide however permanently lowers blood glucose levels by increasing insulin production and could also treat obesity, a major underlying cause of diabetes. A recent study showed that the drug controls appetite and food cravings and could therefore generate significant weight loss.

First developed in 2012, an injectable version of semaglutide is already approved for use in the US. Now, an oral version of the drug has now passed its first Phase III clinical trial.

Semaglutide works by mimicking the action of a hormone (GLP-1) which increases insulin secretion. It can be taken orally once daily and in this 6-month trial was delivered in 3, 6 and 14 mg doses to over 700 people with type 2 diabetes.

The drug showed significant reductions in long-term blood glucose levels compared to placebo at all doses, while the highest dose also led to significant weight loss. People treated with 14mg semaglutide experienced a weight loss of over 4 kg on average.

The drug was also safe and well tolerated, causing only nausea, which reduced over time. Chief Science Officer of Novo Mads Krogsgaard Thomsen said he was encouraged by the results of the trial, adding “[The results] confirm the unprecedented oral efficacy of semaglutide that was reported in the phase 2 clinical trial in type 2 diabetes”.

There are nine additional trials running for semaglutide with over 9000 participants, results for which will be provided later this year. Novo Nordisk plan to apply for regulatory approval for the drug in 2019.

SOURCE: www.hospitalpharmacyeurope.com/editors-pick