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Novartis' psoriasis drug set to challenge Amgen/Pfizer’s Enbrel

Secukinumab shows superior efficacy in phase III trial
Novartis building

Novartis has posted positive results for its investigational psoriasis treatment secukinumab that demonstrate its superior efficacy to Amgen and Pfizer's dominant Enbrel.

According to data from the comparison FIXTURE trial presented this week at the congress of the European Association of Dermatology and Venereology (EADV) in Istanbul, Turkey, nearly twice as many patients on secukinumab experienced significantly clearer skin after 12 weeks of treatment versus Enbrel (etanercept).

The results back earlier positive data posted by Novartis, and the company said it intends to file regulatory submissions for secukinumab in moderate to severe plaque psoriasis by the end of this year.

Specifically, the FIXTURE trial demonstrated that 77 per cent of patients on the 300mg dose of secukinumab achieved a 75 per cent reduction to their score on the Psoriasis Area and Severity Index (PASI) test after 12 weeks.

This compared to 44 per cent of patients on 50mg of Enbrel, meaning the study succeeded in its primary endpoint. For the placebo group, 4.9 per cent of patients achieved a 75 per cent reduction on the PASI, while a 150mg dose of secukinumab saw this result in 67 per cent of patients.

The full study lasted one year, with both the 300mg dose and a 150mg dose of secukinumab achieving secondary endpoints by demonstrating improved efficacy compared to Enbrel throughout the 52 weeks.

Results were also impressive for improving skin condition by a 90 per cent reduction in the PASI score. Just over half of secukinumab 300mg patients reached this level of clear skin at 12 weeks, while 21 per cent of Enbrel patients did.

If approved, secukinumab would offer a serious challenge to Enbrel which, according to Datamonitor, had a 32 per cent share of the $4.5bn severe plaque psoriasis market in 2011. Other drugs in the area include AbbVie's Humira (adalimumab), which recorded 29 per cent of the market share that year.

Both Enbrel and Humira are tumour necrosis factor (TNF) inhibitors and work in the same way to treat a variety of autoimmune conditions.

Secukinumab has a different method of action, blocking the cytokine interleukin-17a (IL-17a), which is involved in the development of psoriasis. It is the first psoriasis treatment to work in this way to reach phase III development.

Novartis is also developing the drug in other autoimmune conditions, including rheumatoid arthritis, ankylosing spondylitis and multiple sclerosis.

Article by
Thomas Meek

4th October 2013

From: Research

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