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Celgene’s Otezla gains new US psoriasis approval

FDA backs oral drug in moderate to severe plaque psoriasis
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The US FDA has approved a second psoriasis indication for Celgene's Otezla.

The oral drug is now available in the US for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.

It adds to Otezla's (apremilast) approval earlier this year for use in the treatment of psoriatic arthritis. It was the first oral drug approved in this indication in the US.

Scott Smith, Celgene's president of inflammation and immunology, said: "The FDA approval of Otezla for plaque psoriasis, together with the previous approval for psoriatic arthritis, reflects Celgene's commitment to extending the reach of our research and science in an effort to improve the lives of people worldwide living with chronic inflammatory diseases."

Otezla is an inhibitor of phosphodiesterase 4 (PDE4), an enzyme linked to inflammatory disorders such as psoriasis, which affects the skin and is thought to affect more than 125 million people worldwide.

The approval was supported by data from two clinical trials - ESTEEM 1 and ESTEEM 2 - conducted in adult patients with moderate to severe plaque psoriasis.

According to Celgene, during these trials patients treated with Otezla “significant and clinically meaningful improvements” in their condition as measured by the Psoriasis Area and Severity Index (PASI).

Otezla will now offer competition to several treatments already on the market for plaque psoriasis, including Pfizer's tumour necrosis factor (TNF) antagonist Enbrel (etanercept) and Johnson & Johnson's Stelara (ustekinumab), an interleukin blocker.

Several other companies also have potential treatments in late stage development. This includes Lilly's interleukin-17 (IL-17) blocker ixekizumab, which recently outperformed Enbrel in a phase III study.

Amgen/AZ's brodalumab has also cleared a late-stage trial, while Novartis has big ambitions for secukinumab, which has also topped Enbrel in comparison studies and has been submitted for approval in Europe, the US and Japan.

Article by
Thomas Meek

25th September 2014

From: Sales, Regulatory



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