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Celgene关节炎药物获得FDA批准

来源:生物谷 2014-03-23 11:37

2014年3月23日讯 /生物谷BIOON/ --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。(生物谷Bioon.com)

详细英文报道:

Celgene ($CELG) picked up the FDA's blessing for the much-debated apremilast, winning approval to market the oral drug as a treatment for psoriatic arthritis in step one of its blockbuster plan.

The drug, to be marketed as Otezla, works by blocking the enzyme phosphodiesterase 4 to reduce swelling in joints and improve physical function in a form of arthritis that afflicts psoriasis sufferers. In its 1,493-patient clinical program, the treatment notched efficacy numbers in the same ball park as on-the-market injectables, and, with a list of most common side effects limited to weight loss, diarrhea, nausea and headache, Celgene's drug will not carry a boxed warning.

And therein lies the bull case for Otezla. The psoriatic arthritis market is largely dominated by injected anti-TNF therapies like AbbVie's ($ABBV) Humira, but such biologics can have nasty side effects that lead some patients to shy away. Celgene believes its oral, small-molecule treatment can provide an attractive alternative.

But the drug's potential is largely tied to whether it can win approval for the broader psoriasis population, and Celgene expects the FDA to weigh in on that indication by September. If regulators give their blessing, the biotech figures Otezla will peak at around $2 billion by 2017. Analysts estimates vary widely on the issue, but the consensus hovers closer to $1.2 billion, according to EvaluatePharma.

"Patients and physicians have expressed their desire for a safe and effective therapy for psoriatic arthritis that has the potential to simplify patient management," Celgene inflammation head Scott Smith said in a statement. "Celgene is excited to be expanding our transformational science into the therapeutic realm of Inflammation and Immunology, with a new approach for patients with psoriatic arthritis."

As part of its approval, the FDA is recommending physicians keep an eye on patients' weight while they take Otezla, and the agency has asked Celgene to amass post-marketing data to ensure the drug is safe for pregnant women.

 

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