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US FDA grants approval to Celgene's Otezla 30mg.

M2 EQUITYBITES-July 23, 2019-US FDA grants approval to Celgene's Otezla 30mg

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The US Food and Drug Administration has granted approval to United States-based Celgene for its Otezla (apremilast) 30mg twice daily, intended to treat adult patients with oral ulcers associated with Behcet's Disease, it was reported yesterday that.

The product is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), particularly for cyclic adenosine monophosphate. It is claimed to be the first and only approved treatment option for oral ulcers associated with Behcet's Disease.

The approval was based on efficacy and safety data from the randomised, placebo-controlled and double-blind phase three Relief study evaluating the product in 207 adult patients with Behcet's Disease with active oral ulcers who were earlier treated with at least one non-biologic medication and were candidates for systemic therapy. According to the company, the results showcased that the product resulted in a 42.7 point decrease from baseline in the pain of oral ulcers as measured by the visual analogue scale at week 12 compared against 18.7 point reduction with placebo. Earlier, Otezla was approved in the use to treat patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and adult patients with active psoriatic arthritis.

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Publication:M2 EquityBites (EQB)
Date:Jul 23, 2019
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