3月21日，FDA批准Celgene的apremilast（商品名Otezla），用于治疗银屑病关节炎（PsA）。apremilast (CC-10004)是PDE4抑制剂，III期临床试验中Otezla组与安慰剂组的ACR20应答率分别为32-41%、18-19%。
 

Celgene生物技术公司开发的治疗关节炎药物apremilast获得了FDA的批准。FDA批准其作为治疗银屑病性关节炎的口服药物上市。这种将以Otezla为商品名上市的新药物是一种磷酸二酯酶抑制剂，能够减轻关节肿胀并改善关节部位的生理机能。在一项有1493名患者参与的临床研究中，apremilast相对于市面上的注射类药物有很大的改善。

目前银屑病性关节炎市场上的药物一般是抗TNF类药物，例如艾博维生产的Humira，这种药物具有很大的副作用会导致患者出现严重不良反应。因此Celgene公司的apremilast具有很大的优势。不过apremilast能取得多大的成功还取决于FDA，Celgene公司将于9月份再次向FDA提交申请，扩大apremilast的适用人群。一旦获得批准，apremilast的销售额预计最高将达到20亿美元。 

FDA approves Otezla to treat psoriatic arthritis

The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).

PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. Joint pain, stiffness and swelling are the main signs and symptoms of PsA. Currently approved treatments for PsA include corticosteroids, tumor necrosis factor (TNF) blockers, and an interleukin-12/interleukin-23 inhibitor.

“Relief of pain and inflammation and improving physical function are imp0rtant treatment goals for patients with active psoriatic arthritis,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug eva1uation II in the FDA’s Center for Drug eva1uation and Research. “Otezla provides a new treatment option for patients suffering from this disease.”

The safety and effectiveness of Otezla, an inhibitor of phosphodieasterase-4 (PDE-4), were eva1uated in three clinical trials involving 1,493 patients with active PsA. Patients treated with Otezla showed improvement in signs and symptoms of PsA, including tender and swollen joints and physical function, compared to placebo.

Patients treated with Otezla should have their weight monitored regularly by a healthcare professional. If unexplained or clinically significant weight loss occurs, the weight loss should be eva1uated and discontinuation of treatment should be considered. Treatment with Otezla was also associated with an increase in reports of depression compared to placebo.

The FDA is requiring a pregnancy exposure registry as a post-marketing requirement to assess the risks to pregnant women related to Otezla exposure.
 
 

In clinical trials, the most common side effects observed in patients treated with Otezla were diarrhea, nausea, and headache.

Otezla is manufactured for Celgene Corporation, Summit, N.J.

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