5月8日消息 - 环球医学据悉，美国药物评论员表示，Regeneron制药公司防止痛风的药物有效，但质疑其副作用以及是否足以帮助患者。

上周五，FDA的工作人员表示，该注射用药物Arcalyst（利纳西普）计划只使用16周来防止痛风-这是首个以这么短的时间来治疗该疾病的药物。

FDA的工作人员在外部专家咨询小组之前对此进行了审查，专家咨询小组将在下周二投票决定是否推荐该药物。FDA将考虑该小组的建议，在7月30日作出最后决定。

Regeneron公司的药物已经批准用于治疗一组罕见的遗传性炎症性疾病。但该小型生物技术公司希望扩大其使用范围，用于防止开始尿酸降低治疗的患者的痛风。

FDA的工作人员表示，虽然已经有痛风的一般治疗，但还没有专门用于开始降低尿酸治疗的患者的药物，也没有仅仅只使用16周的药物。

根据上周五发布在网上的文件，工作人员说：“从有效性的角度来看，重要的是需要阐明在开始治疗（降低尿酸治疗）期间治疗16周是否足以防止潮红。”

FDA工作人员还表示，Regeneron公司的药物是一种注射用的抑制免疫系统的生物制剂，这可能会增加癌细胞的数量。在临床试验中，6例接受Arcalyst治疗的患者患恶性肿瘤，而接受安慰剂的患者没有发生恶性肿瘤。

然而，FDA的工作人员表示，16周的治疗时间相对较短，使得它不太可能引起肿瘤-虽然Arcalyst与安慰剂之间的不平衡仍然会引起关注。（环球医学）

原文：

FDA Staff Question Effects of Regeneron Gout Drug

U.S. drug reviewers said Regeneron Pharmaceuticals Inc's drug to prevent gout flares worked, but questioned its side effects and whether it did enough to help patients.

The Food and Drug Administration staff on Friday said the injectable drug Arcalyst (rilonacept) was meant to be used for only 16 weeks to prevent gout flares -- the first treatment for the condition with such a limited timeline.

The FDA staff review comes ahead of an advisory panel of outside experts, which will vote on whether to recommend the drug next Tuesday. The FDA will make a final decision by July 30, taking into account the panel's recommendations.

Regeneron's drug is already approved to treat a group of rare genetic auto-inflammatory diseases. But the small biotech company is hoping to expand its use to prevent gout flares in people starting uric acid-lowering therapy.

While there are already treatments for gout flares in general, none exist specifically for people who are starting therapy to lower their uric acid, and none is meant to be used for only 16 weeks, the FDA staff said.

"From an efficacy standpoint, it will be important to address whether 16 weeks provide for an adequate duration for flare prophylaxis during initiation of (uric acid-lowering therapy)," the staff said, according to documents posted online on Friday.

The FDA staff also said Regeneron's drug, which is an injectable biologic, suppresses the immune system, which could increase the number of cancerous cells. Six people treated with Arcalyst during clinical trials developed malignancies compared to zero for those taking a dummy drug during the trials.

However, the FDA staff said the treatment duration of 16 weeks was relatively short, making it less likely the drug caused tumors -- though the imbalance between Arcalyst and placebo still raised concerns.