Category Archives: Dermatology

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

Risankizumab approval could strengthen AbbVie’s market position

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

According to GlobalData, if approved, risankizumab would further strengthen AbbVie’s position in the psoriasis market.

If European approval is granted for AbbVie’s risankizumab for moderate-to-severe plaque psoriasis, the company could further strengthen its position in the psoriasis market, according to GlobalData, a leading data and analytics company.

In 2017, AbbVie reported that Humira (adalimumab), an anti-tumour necrosis factor (TNF) biologic indicated for multiple immunological disorders including psoriasis, generated global sales of $18.42 billion, accounting for 65% of AbbVie’s total net revenue.

Risankizumab is an investigational compound that has been designed by AbbVie to selectively inhibit IL-23 by binding to its subunit p19. AbbVie has submitted a marketing authorisation application (MAA) for risankizumab to the European Medicines Agency (EMA).

Vikesh Devlia, Pharma Analyst at GlobalData, said: “With the anticipated launch of Humira biosimilars in the EU starting from October 2018, AbbVie’s position is threatened in the psoriasis market by both biosimilar erosion and other major pharma companies gaining approval for their IL-17 and IL-23 biologics.”

“This may not affect AbbVie immediately, since physicians will likely continue to prescribe Humira as one of their first-line biologic therapies for moderate-to-severe psoriatic patients. However, the less frequent dosing of IL-17 and IL-23 biologics could shift physicians to opt for these therapeutics eventually.”

“Despite these challenges, AbbVie intends to remain a player within the changing field of psoriasis treatment. With the submission of an MAA for risankizumab, the company could be closer to retaining a strong position in the psoriasis space.”

The currently approved IL-23 inhibitors for psoriasis include Johnson and Johnson’s Tremfya (guselkumab) and Sun Pharma’s Ilumya (tildrakizumab).

Both Tremfya and Ilumya have been shown to have high efficacy in moderate-to-severe psoriasis.

Devlia added: “Although there are not yet any head-to-head trials comparing the efficacy of these drugs to one another, it is clear from Phase III trials that risankizumab and Tremfya will compete for best-in-class status, as both IL-23 drugs deliver high efficacy for moderate-to-severe psoriasis patients.”

SOURCE: www.manufacturingchemist.com/news

Vytrus Biotech launches new skin repairing active ingredient

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

An excess and accumulation of fat can have very negative effects on skin and body, accelerating ageing and creating sagging of the skin, among others.

Vytrus Biotech presents SARCOSLIM RE-SHAPE PRCF, an active ingredient that introduces the new concept of Liposculpture: a skin remodelling system that helps reduce fat, while taking advantage of the intercellular energy released through the burning of this fat to tighten and reaffirm tissue, so specific parts of the body can be sculpted at will.

The skin acquires a younger and firmer aspect from the ‘inside’. Liposculpting is exactly what the company’s new active achieves: reshaping your curves at will, while improving your skin structure.

The ingredient SARCOSLIM RE-SHAPE PRCF (INCI name: Sarcocapnos Crassifolia callus lysate), is made from totipotent cells (plant stem cells) of the endemic, and close to extinction South-Iberian plant, Sarcocapnos crassifolia, through the company’s technology platform, PLANT CELL BIOFACTORIES.

This active is a metabolome rich in plant lipid management related factors (fumaric acid: skin regeneration and anti-inflammation, and isoquinolinic alkaloids: fat burning signals), specially designed to produce fat burning, and traduce it in an increase of cell energetic metabolism, and a reactivation of the mechanical properties of skin: it reduces the cutaneous lipid content, harnessing the extra energy to rebuild the skin, and to keep each curve in place.

The product is Ecocert certifiable, and free of GSO, BSE, parabens, Phenoxyethanol, pesticides and contaminants.

The applications of the ingredient go from reducers of rebel volumes to cellulite treatments, treatment of double chin, anti-eye bags, lack of tone, contour remodeling, smooth orange skin, firming, treatments for sagging and treatments for specific needs of neck, décolletage and breasts.

Several tests have been performed to validate these claims:

  • In Vitro tests demonstrate the ingredient’s anti-inflammatory and antioxidant properties.
  • Ex Vivo tests on skin explants were performed to proof its Lipolytic effect, skin restructuration and metabolic activation. There was reduction of the lipid content in both the dermis and adipose tissue, indicating a global lipolytic effect in the explants The product also shows an excellent capacity to protect and repair the dermal fibers, that guarantees a restructuring and reaffirmation of the tissue.

In Vivo studies evaluated the firming and slimming effect in face and body, and reshaping effect on ptosis, on volunteers, both in presence and absence of caloric restriction, demonstrating:

  • Facial firmness & elasticity increase despite the diet
  • Body firmness & elasticity increase despite the diet
  • Remodeling effect (Ptosis & sagging reduction)
  • Diet slimming equivalent effect
  • Targeted slimming

In Vivo Evaluation of the FIRMING effect:

  • Double blind study vs. Placebo
  • 30 Volunteers with overweight, BMI (Body Mass Index) 25-30 Kg/m2
  • Two groups of volunteers are established:
  • Group with nutritional monitoring: a moderate reduction in caloric intake
  • Group without nutritional monitoring
  • SARCOSLIM RE-SHAPE PRCF 1.5% dosage
  • Panels of mixed volunteers: 23-29% men and 71-77% women. Age 31-49 years
  • Areas of application: Men: face & abdomen; Women: face & hips Firmness & elasticity measurements by cutometer
  • 56 days – 2 daily applications

Evaluation of Facial and Body Skin Elasticity improvement

SARCOSLIM RE-SHAPE PRCF increased the facial elasticity up to +10 % in the group with NO diet, and increased the facial elasticity up to +10 % in the Diet group, both at 56 days.The same effect was demonstrated with body elasticity, that was increased up to +9.8 % in the No Diet group and up to +7.2 % in the Diet, group at 56 days.

Evaluation of Facial and Body Skin Firmness improvement

SARCOSLIM RE-SHAPE PRCF increased the facial firmness up to +7.6 % in the group without Diet, and up to +14 % in the group with Diet, at 56 days. The ingredient also increased the body firmness up to +8.6 % in No Diet group, and up to +12 % in the Diet group at 56 days.

The studies demonstrate that SARCOSLIM RE-SHAPE PRCF produced significant firming and elasticity boosting effects which were equivalent in intensity both in face and body (hips in women and abdomen in men).

The active ingredient is especially effective in the group with caloric restriction, where skin firming is more challenging, due to weigh loss.

1. In Vivo Evaluation of the SLIMMING effect

  • Simple blind intra-individual study vs. placebo
  • Women with excess local fat in hips
  • BMI (Body Mass Index, Kg/m2) = 23-30 (overweighed without reaching obesity)
  • Group with diet: 16 vol., 20-45 years (35 ± 3), body application
  • Group without diet: 16 vol., 40-55 years (48 ± 1), body application
  • SARCOSLIM RE-SHAPE PRCF 3% dosage
  • Slimming effect: weight control (kg) & perimeter control of thighs (cm)
  • Reshaping effect (group with no diet): Volume of ptosis or sagging in face (ml)
  • Areas of application: hemi-corporal (hips and thighs) vs placebo
  • 56 days – 2 daily applications

Evaluation of the facial remodelling effect

The volunteers were women presenting ptosis or facial sagging, and were asked to maintain stable weight without modifying life habits. Group with No Diet. 15 vol., 40-55 years old (48 ± 1), Hemi-facial application vs. placebo.

IMAGE 1: Reduction of Ptosis volume

SARCOSLIM RE-SHAPE PRCF showed a significant reduction of facial sagging of up to -18%*, showing a clear re-shaping effect.

The measurements were done with FACESCAN, and the color codifies and defines the increase and decrease in volume. In the images it can be observed that the volume reduction indicates a more defined facial contour line, being the reduction of the volume of ptosis (ml) indicated in the blue zone, demonstrating the remodeling effect of SARCOSLIM RE-SHAPE PRCF.

IMAGE 2: Facial Countour Remodeling

Evaluation of the slimming effect

No Diet: reduction of tight perimeter of up to -3cm, with a significant average reduction of -1.4 cm. This test was effective in 100% of volunteers.

Diet: reduction of the thigh perimeter of up to -5.6cm, with a significant average reduction of -3.8 cm*. This test was also effective in 100% of volunteers.

These results demonstrate the ability of the ingredient to perform a targeted slimming effect on specific zones, and there is an effect equivalent to having done a diet of up to -3.75 kg weight loss, demonstrating the synergistic effect with diet.

SOURCE: www.cosmeticsbusiness.com/news

Skin conditions cost NHS £723m a year

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

New research shows that more than three million primary care hours are spent on skin conditions, at a cost to the NHS of £723 million each year.

The research, carried out by the Association of the British Pharmaceutical Industry in collaboration with an independent Dermatology Expert Working Group (EWG), highlights the burden of skin conditions on both patients and the NHS.

According to the findings, around 13.2 million people in England visited their GP with a skin problem in 2016, of which 85 percent said the psychosocial aspects of their condition were a significant part of their illness.

The research also showed that almost 60 percent of patients with severe psoriasis could lose up to 26 days of work a year because of their skin condition.

“Today’s findings bring into sharp focus the staggering amount of time and money the NHS spends on the management of skin conditions in primary care and the significant impact skin conditions can have on people’s lives,” said EQG chair Rt Hon Professor Paul Burstow.

“Ignore dermatology and we miss a huge opportunity to make real and immediate gains for the NHS and for people’s quality of life.”

The group’s report, Making real our shared vision for the NHS: optimising the treatment and care of people with long-term skin conditions in England, makes a stream of recommendations designed to drive efficiencies and improve patient outcomes.

It calls on NHS England to promote and support successful self-management through patient education programmes for specific long-term skin conditions, led by suitably trained healthcare professionals (HCPs), as well as promote promote and incentivise the adoption of technology such as email guidance and smartphone apps.

NHS England should also put in place suitable incentives to encourage commissioners to implement teledermatology pathways to triage patients with skin lesions appropriately and free up face-to-face time for clinicians to see patients with inflammatory skin conditions, it said.

SOURCE: www.pharmatimes.com/news

Amryt looking to expand rare disease franchise

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

UK-based specialist Amryt Pharma is looking to expand in 2018 after acquiring two rare disease treatments.

A relative newcomer to the niche rare disease market, Amryt Pharma was founded by former Astellas medical director Joe Wiley and financier Rory Nealon in August 2015, who spotted an opportunity to develop products in under-served orphan disease therapy areas.

The Irish duo in-licensed their first product, Lojuxta from Aegerion in December 2016, and have since increased its revenues by more than 50%, as well as building a corporate team and European operations.

Lojuxta is licensed to treat the rare, life-threatening disease called Homozygous Familial Hypercholesterolemia (HoFH), and Amryt has marketing rights for the drug in the EEA region, as well as Israel, Turkey and MENA markets.

The company also has in its pipeline AP101, a promising product candidate currently in a pivotal trial for epidermolysis bullosa, a rare and debilitating skin condition.

Amryt expect to bring the product to the US and European markets by 2020, and believe the global market to treat the condition is worth around $1 billion annually.

“This is an exciting time of growth and expansion for us. Rare disease companies often start up in the US and then enter the European market, but our origins mean we have a deep understanding of what’s required and the nuances of doing business in the pharmaceutical space in Europe,” said Joe Wiley.

“I believe we’re proving this with the significant growth we have delivered in the space of one year with Lojuxta.”

The privately-held company is expected to look for further growth this year, and this includes interest in further in-licensing deals.

Meanwhile, the company is planning a paediatric study for Lojuxta and is currently awaiting sign off for its study design from the EMA.

The company is also pursuing additional licences for AP101.

“We’re planning to study other severe partial thickness wound conditions, such as Toxic Epidermal Necrolysis (TENs) / Stevens Johnson Syndrome (SJS), a rare, serious disorder of skin and mucous membranes. These are being planned in parallel in order to maximise the potential value of the AP101 asset for Amryt, our shareholders and most importantly for patients.”

Plans to enter US market

As for expansion into the US, the company says it already has its first “boots on the ground” in the US and in Latin America, its teams there establishing the opportunities in the market and meeting with relevant stakeholders.

“The EB market is particularly appealing in the US – there are approximately 20 centres focusing on EB, therefore it makes it easier for a small, agile company like Amryt Pharma to work closely with them,” says Wiley.

“We can offer patients what they need as we seek to improve their quality of life, with more effective wound care.”

The design of the global trial for AP101 has already been agreed with the FDA, and the company is currently completing the pre-clinical package and preliminary safety data set the US regulator has requested in order to open the IND specific to the US.

Amryt won’t have the EB market to itself, however, and a number of companies are developing novel treatments for the condition.

These include US-based Fibrocell Science, which has just got the green light to begin phase 2 trials of its gene therapy candidate FCX-007 for recessive dystrophic epidermolysis bullosa (RDEB).

Another company in the field is Netherlands-based ProQR Therapeutics, which is working on an RNA-based therapy for dystrophic epidermolysis bullosa (DEB).

Interim analysis of the data from Amryt’s EASE trial will be available later in 2018, followed by top-line analysis.

The company expects to compile its submissions to the FDA and EMA shortly thereafter, with marketing authorisation in Europe and US anticipated late 2019, or possibly early 2020.

SOURCE: www.pharmaphorum.com/news

US Startup Claims It Is Regenerating Skin With Stem Cells

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

A tiny Utah biotech firm is making waves in regenerative medicine.

Last summer, it made headlines for successfully regenerating skin and stimulating hair growth in pigs with burns using a stem cell therapy. Now, the company says its therapy is working on a badly burned 10-year-old boy.

The Salt Lake City Tribune reports that the firm, PolarityTE, is now testing its treatment at more than a dozen hospitals around the country. But, the paper reported, the company has only disclosed the name of one of those hospitals. And its therapy, called SkinTE, did not endure the rigor of traditional phased clinical trials, nor evaluation by federal regulators, due to the way it is registered with the Food and Drug Administration. But perhaps most bizarre detail of all is how the company raised funding: Rather than turn to traditional VC investors, it merged with a failing, publicly traded video game company, arriving on the NASDAQ in March with the stock ticker “COOL.”

The company’s therapy is a stem cell mixture intended to be spread in a thick paste over burns. Skin grafts are the typical treatment for burn victims, but they are thin and fragile and cannot grow hair, making the quest to successfully regenerate skin a sort of biomedical holy grail. In November, Italian researchers announced that they were able to almost entirely reconstruct the skin of a seven-year-old boy afflicted with a painful genetic condition that effects the skin using a combination of stem cells and gene therapy.

In a press release by the company earlier this month, a New Orleans doctor at the Children’s Hospital in New Orleans stated that “the product has quickly regenerated skin with minimal marginal wound contracture and areas of regenerated skin are re-pigmenting rapidly.” The company’s CEO told the Salt Lake City Tribune that the therapy will “change the face and practice of regenerative medicine” for burn victims and others with deep wounds.

But the company has attracted sceptics, and it highlights the troubles that plague stem cell products. SkinTE is registered with the FDA as a human cellular and tissue product, which drastically reduces the number of hurdles it must clear to be marketed commercially. In general, the FDA’s regulatory approach is risk-based, with fewer regulations applying to products that are considered less risky. Stem cells procedures like PolarityTE’s often fall into that category because cells are harvested from a patient’s own body, making adverse effects less likely. But that doesn’t mean that the therapies will work, just that the agency thinks they are unlikely to harm someone. In October, the firm White Diamond Research issued a 14-page critique of the PolarityTE, saying it lacks data necessary to convince physicians it will work. For now, whether it’s the breakthrough it claims to be is hard to judge. [Salt Lake City Tribune]

SOURCE: www.gizmodo.co.uk/2018/02

Psoriasis drug found to reduce aortic vascular inflammation

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

An antibody used to treat the skin disease psoriasis is also effective at reducing aortic inflammation, a key marker of future risk of major cardiovascular events.

An antibody used to treat the skin disease psoriasis is also effective at reducing aortic inflammation, a key marker of future risk of major cardiovascular events.

Researchers from the Perelman School of Medicine at the University of Pennsylvania, in collaboration with the National Heart, Lung, and Blood Institute, led a randomised, double-blind, placebo-controlled study and found patients who took the drug ustekinumab had a 19 percent improvement in aortic inflammation, as measured and confirmed by imaging, when compared to the placebo group. Dr Joel M. Gelfand, a Professor of Dermatology and Epidemiology at Penn and the study’s first author.

Ustekinumab, sold under the name Stelara, is approved by the US Food and Drug Administration to treat psoriasis, psoriatic arthritis, and Crohn’s Disease. Researchers wanted to know if the benefits of the drug go beyond clearing the skin.

“The type of inflammation we see in psoriasis is similar to what we see in atherosclerosis – a type of heart disease that involves the build-up of fats, cholesterol, and inflammatory cells in the artery walls,” Dr Gelfand said. “Since ustekinumab blocks the specific pathways involved in both skin and cardiovascular inflammation, we wanted to test whether it can improve aortic vascular inflammation.”

Psoriasis patients were randomly divided into two groups, with 21 patients in the placebo group and 22 patients receiving the treatment. The primary outcome was aortic inflammation, as measured by 18-FDG-PET/CT scans – an imaging technique that reveals inflammation in the aorta. The imaging was performed before treatment and at 12 weeks. The treatment group saw a 6.6 percent decrease in aortic inflammation, while the placebo group saw a 12 percent increase, meaning the drug is responsible for a 19 percent improvement relative to untreated patients. As expected, ustekinumab also resulted in a dramatic improvement in skin inflammation as well, with 77 percent of treated patients achieving a 75 percent or better improvement in psoriasis activity, compared to just 10.5 percent in the placebo group. Both findings were highly statistically significant (p?0.001).

The results are consistent with a previous, smaller uncontrolled trial of ustekinumab, but they are in direct contrast to two large trials using a different drug called adalimumab, which is sold as Humira.

“This is the first placebo-controlled trial of a biologic drug to show a benefit in aortic inflammation, a key marker of cardiovascular disease,” Dr Gelfand said. “The effect is similar to what we would expect if we put the patient on a statin.”

Dr Gelfand, who conducted the study in collaboration with Dr Nehal N. Mehta, Chief of the Section of Inflammation and Cardiometabolic Diseases at the National Heart, Lung, and Blood Institute, confirmed their results by having a second, separate lab independently evaluate imaging data.

“This study represents a promise that this treatment may reduce the risk of heart attack and stroke in the future. It’s an encouraging finding,” Dr Gelfand said.

The trial is ongoing, and Dr Gelfand says his team will evaluate these patients at a longer follow up to see if the effects are sustainable and if patients continue to improve.

SOURCE: www.europeanpharmaceuticalreview.com/news/72839

AbbVie reports more solid data for would-be psoriasis blockbuster

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

AbbVie thinks it could have a best-in-class immunotherapy drug with its interleukin-23 blocker risankizumab, and updated results in psoriasis won’t undermine that view.

A pair of phase III trials pitting risankizumab against Johnson & Johnson’s older IL-12/IL-23 inhibitor Stelara (ustekinumab) – reported at the American Academy of Dermatology meeting in Chicago over the weekend – found that it was much more likely to clear skin in patients with moderate to severe plaque psoriasis.

The new drug will need to show stellar efficacy if it is to make headway in the increasingly crowded psoriasis market, and the results from the ultIMMa-1 and ultIMMa-2 seem to keep it on track. The data reveal a superior profile to Stelara as an active control, with up to 60% of patients on the drug reporting clear skin after a year compared to 21%-30% with Stelara.

AbbVie’s drug is in hot pursuit of the only approved IL-23 inhibitor on the market – J&J’s Tremfya (guselkumab) – and some analysts including Leerink’s Geoffrey Porges have suggested trials to date show risankizumab might be a little better than its rival with the potential for less frequent dosing.

Its profile could also help it make headway against other new psoriasis drugs, including IL-17 inhibitors such as Novartis’ fast-growing Cosentyx (secukinumab) as well as Eli Lilly’s Taltz (ixekizumab) and Valeant’s Siliq (brodalumab).

New drugs are starting to chip away at the dominance of AbbVie’s anti-TNF drug Humira (adalimumab) in psoriasis and other indications like rheumatoid arthritis, although it still dwarfs them with sales of more than $18bn last year and remains the world’s biggest-selling pharma product.

Risankizumab’s data could propel it above the $1bn threshold in psoriasis alone, according to Leerink, with additional upside if it gets approved in other indications such as psoriatic arthritis and Crohn’s disease.

Meanwhile, AbbVie also reported positive phase IIb results with its new oral JAK1 inhibitor upadacitinib – another drug considered to a key pipeline prospect and potential blockbuster – in adults with moderate to severe atopic dermatitis (eczema) at the AAD.

The latest data, updating earlier results reported last year, showed that upadacitinib was able to significantly reduce the itch associated with atopic dermatitis after just one week and improved the extent and severity of skin lesions at week two.

Upadacitinib is vying to become the third drug in the class after Pfizer’s Xeljanz (tofacitinib) and Eli Lilly’s Olumiant (baricitinib) as a rheumatoid arthritis treatment, reporting encouraging phase III data last year, and is also in pivotal trials for psoriatic arthritis and Crohn’s disease.

AbbVie now says it plans to begin pivotal studies in atopic dermatitis, as well as ulcerative colitis and giant cell arteritis before the end of the year. Upadacitinib (also known as ABT-494) has been tipped by some analysts as a future leader of the JAK inhibitor category with sales of up to $3.5bn at peak.

SOURCE: http://www.pmlive.com/pharma_news

FDA expands Janssen’s Stelara to cover adolescent psoriasis patients

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Janssen has announced that the FDA has approved an expanded indication for its psoriasis therapy Stelara (ustekinumab) for the treatment of moderate to severe plaque forms of the disease in adolescent patients aged 12 or over who are candidates for phototherapy or systemic therapy.  

The decision was built upon Phase 3 data which demonstrated that Stelara produced response at a week 12 primary endpoint after subcutaneous administration of two doses at weeks 0 and 4, defined by achieving a Physician’s Global Assessment (PGA) score of 0 or 1, which relates to achievement of full clearance or minimal traces of the disease.

“Psoriasis can affect many aspects of everyday life and the visible plaques, itching and discomfort can take a particular toll on adolescents,” said Dr Andrew Greenspan, Vice President of Medical Affairs at Janssen. “With today’s approval, Stelara has the potential to make a meaningful difference in the lives of these young adults.”

Around 80-90% of psoriasis sufferers are affected by the plaque variation of the disease, and one-third of these individuals develop it before they turn 20. As there are limited treatment options in treating the illness within this age group, the FDA’s decision could mean big things for adolescents with psoriasis.

“Psoriasis is a highly visible disease, and it is essential that these younger patients and their caregivers have options that can effectively reduce the difficult-to-conceal and often misunderstood plaques,” said Dr Michael Siegel, Senior Vice President of Research and Clinical Affairs for the National Psoriasis Foundation. “It is encouraging to have new treatment options where few exist for adolescents living with psoriasis during such formative times in their lives.”

SOURCE: www.pharmafile.com/news/515397