FDA批准Xiaflex治疗Peyronie病

美国食品药品管理局(FDA)已核准将生物制剂Xiaflex（溶组织梭菌胶原酶）用于治疗Peyronie病，这使其成为首个经FDA批准用于治疗该病男性患者的药物。

Xiaflex最初于2010年被批准用于治疗手畸形Dupuytren挛缩，也是Peyronie病的第一种非手术治疗选择。这种疾病的特征为阴茎下皮肤产生瘢痕组织，形成肿块。这种瘢痕组织可导致勃起过程中发生异常弯曲，造成性交时的不适。

FDA在12月6日的声明中指出：“目前认为，Xiaflex治疗Peyronie病的机制是破坏导致挛缩畸形的胶原形成。”

一个Xiaflex治疗周期包括向阴茎的含胶原部分直接注射2次和一个阴茎塑型的过程。患者可接受不超过4个周期的治疗。

两项试验中对832例患有Peyronie病且阴茎挛缩畸形至少30度的男性患者进行了研究。患者接受安慰剂或不超过4个周期的Xiaflex治疗，并随访52周。

FDA报告 ，与安慰剂相比，Xiaflex“显著减少阴茎挛缩畸形和相关困扰”，但同时警告需注意药物治疗可能产生的不良反应，如阴茎断裂、血肿、肿胀和疼痛。

鉴于存在不良反应的风险，仅可在风险评估和减轻策略的指导下依循受限的程序使用Xiaflex 治疗Peyronie病。这一程序要求参与的医生接受培训和获得使用该药的证书。

应将Xiaflex使用过程中发生的不良反应报告至FDA的MedWatch不良事件报告系统，可在线报告或致电800-FDA-1088。

Xiaflex的销售商为Auxilium制药公司。

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By: MADHU RAJARAMAN, Internal Medicine News Digital Network

The Food and Drug Administration has approved the biologic drug Xiaflex (collagenase clostridium histolyticum) for Peyronie’s disease, making it the first FDA-approved medicine for men with the disease.

Xiaflex, originally approved in 2010 to treat the hand deformity Dupuytren’s contracture, is the first available nonsurgical treatment option for Peyronie’s disease, a condition in which scar tissue develops under the skin of the penis to form a lump. This scar tissue causes an abnormal bend during erection that may cause discomfort during intercourse. 

"Xiaflex is believed to work for Peyronie’s disease by breaking down the buildup of collagen that causes the curvature deformity," the FDA said in a statement Dec. 6.

A treatment cycle with Xiaflex consists of two injections directly into the collagen-containing part of the penis and one penile modeling procedure. The patient may undergo a maximum of four treatment cycles.

Xiaflex was studied in two trials of a total of 832 men with Peyronie’s disease and a penile curvature deformity of at least 30 degrees. Patients received either placebo or up to four Xiaflex treatment cycles and were followed over 52 weeks.

The FDA reported that Xiaflex "significantly reduced penile curvature deformity and related bothersome effects" compared with placebo, but warned of possible adverse side effects of the drug, such as penile fracture, hematoma, swelling, and pain.

Because of the risk for adverse reactions, Xiaflex for the treatment of Peyronie’s disease is available only through a restricted program under a Risk Evaluation and Mitigation Strategy. The program requires participating doctors to undergo training and certification in the administration of the drug.

Adverse reactions from the use of Xiaflex should be reported to the FDA’s MedWatch Adverse Event Reporting Program online or by calling 800-FDA-1088.

Xiaflex is marketed by Auxilium Pharmaceuticals.