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FDA拒绝扩大Regeneron公司痛风药物Arcalyst的使用

来源:环球医学编译    时间:2012年08月01日    点击数:    5星

8月1日消息--环球医学据悉,Regeneron制药公司表示,美国监管机构拒绝批准其药物Arcalyst扩大应用于预防痛风急性发作,并要求该公司提供更多的临床数据。

当美国食品和药物管理局的专家小组关注到该公司只完成了16周的研究,全票反对拒绝了由其在五月初审批的药物。

Regeneron公司在一份声明中说,该机构已被要求补充额外的临床资料,包括与为注射用药物Arcalyst建议的新剂型相关的化学、生产和对照信息。

原以高昂的热情期望获得治疗痛风急性发作的药物Arcalyst审批的Regeneron公司称,应FDA要求,目前已经开始对尿酸降低疗法进行研究。

由于机体的废弃产物尿酸沉积在关节和软组织处,所以痛风患者经受着剧烈的疼痛和炎症的折磨。

众所周知,作为rilonacept,Arcalyst已经上市用于治疗罕见的遗传性自身炎症性疾病。它仅仅有助于适度提升Regeneron公司的整体销售业绩。

Regeneron公司由于最近获批用Eylea治疗黄斑变性(中老年人失明的首要原因)而出名。4月至6月间,arcalyst带来销售收入为600万美元,而Eylea的销售则上涨了57%达1.94亿美元。

总部位于纽约的Regeneron公司的股票在纳斯达克周一收盘时为135.47美元。(环球医学)

原文

FDA rejects expanded use of Regeneron drug for gout


(Reuters) - Regeneron Pharmaceuticals Inc said U.S. regulators have denied approval for it to expand use of its Arcalyst drug to prevent gout flares, asking that the company provide more clinical data.

The rejection follows a unanimous vote against the drug's approval in early May by advisors to the U.S. Food and Drug Administration, with panel members expressing concern that the company had only done a 16-week study.

The agency has requested additional clinical data, including chemistry, manufacturing and controls information related to a proposed new dosage form for the injectable drug, Arcalyst, Regeneron said in a statement.

Regeneron, which had pitched Arcalyst for approval to treat gout flares in patients starting uric acid-lowering therapy, said it was reviewing the FDA's requests.

Patients afflicted with gout experience severe pain and inflammation due to deposits of uric acid -- a body waste product -- in the joints and soft tissues.

Known generically as rilonacept, Arcalyst is already on the market to treat a group of rare genetic auto-inflammatory diseases. It only contributes modestly to Regeneron's overall sales.

Regeneron is better known for its recently approved Eylea to treat macular degeneration, the leading cause of blindness in the elderly. Arcalyst brought in sales of $6 million in the April-June period, while Eylea's sales shot up 57 percent to $194 million.

New York-based Regeneron's shares closed at $135.47 on Monday on the Nasdaq.


       相关链接:http://www.reuters.com/article/2012/07/31/us-regeneron-arcalyst-idUSBRE86U03Z20120731

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