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Novartis' Cosentyx beats Stelara in psoriasis study

Cosentyx achieved clearance in 70% of patients

Novartis building 

Novartis has chalked up another positive head-to-head trial for its psoriasis candidate Cosentyx, this time showing superiority to Johnson & Johnson's Stelara.

The phase III CLEAR study showed that Cosentyx (secukinumab) was able to achieve clear or almost clear skin in a significantly higher proportion of patients than Stelara (ustekinumab), a big-selling treatment for psoriasis that sold $1.5bn in the first nine months of the year.

The earlier FIXTURE trial of Cosentyx - an interleukin-17 (IL-17) inhibitor - showed the drug was more effective in clearing psoriasis skin lesions than Amgen's Enbrel (etanercept), another widely-used biologic therapy for psoriasis.  

In phase III trials, Cosentyx has achieved 100% or 90% clearance on the psoriasis area and severity index (PASI 100 or 90 score) in 70% or more of treated patients within 16 months of starting treatment.

"Achieving clear skin is the ultimate aim of psoriasis treatment for patients," said the company in a statement, adding that its research has shown a significant positive relationship with health-related quality of life scores when most or all lesions are resolved.

At the moment, around half of all psoriasis patients are not happy with their treatment, including biologic therapies which provided a dramatic increase in efficacy when introduced a few years ago.

Cosentyx has already been recommended for approval in Europe and is expected to get a final green light from the EMA early next year. Meanwhile, in the US the drug was backed by an FDA advisory committee in October and - assuming the FDA follows its panel's advice - is due for approval in or before March 2015.

Cosentyx has a lead over rival IL-17 inhibitors brodalumab from Amgen and AstraZeneca (AZ), which is due for filing in 2015 and has also shown superiority to Stelara in a head-to-head trial, as well as Eli Lilly's ixekizumab which has also cleared phase III trials.

Analysts at Kepler Chevreux previously indicated they expect Cosentyx to achieve peak sales of around $700m in 2020, although others are more optimistic and say it could breach the $1bn-a-year barrier by that time. The drug is also in clinical development for psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with filings due during 2015.

Article by
Phil Taylor

12th December 2014

From: Research

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