Agents for Peyronie’s, prostate Ca closer to FDA nod

Agents in the pipeline for the treatment of Peyronie’s disease and castration-resistant prostate cancer have moved closer to FDA approval, their developers reported.

The FDA has accepted for filing and granted standard review status to Auxilium Pharmaceuticals’ supplemental biologics license application for collagenase clostridium histolyticum or CCH (Xiaflex), an in-office biologic therapy for the potential treatment of Peyronie’s disease. Under the Prescription Drug User Fee Act, the FDA is expected to take action on the application by Sept. 6, 2013.

The agent is currently approved in the U.S., European Union, Canada, and Switzerland for the treatment of adult Dupuytren’s contracture patients with a palpable cord. Its use for the treatment of Peyronie’s disease was granted orphan designation in the U.S. by the FDA in January 1996 and, if approved by the FDA, is expected to be the first and only biologic therapy indicated for the treatment of Peyronie’s.

The application is based on data from clinical studies in which CCH demonstrated statistically significant improvement in the co-primary endpoints of penile curvature deformity and patient-reported bother versus placebo. The most common treatment-related adverse events reported in phase III studies were local to the treatment site and consistent with adverse events reported in previous Peyronie’s trials with CCH.

Separately, Bayer HealthCare announced that it has submitted a new drug application to the FDA seeking approval for radium Ra 223 dichloride (radium-223), an investigational compound for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases.

Radium-223 was granted fast track designation by the FDA, designed to facilitate the development and expedited review of drugs to treat serious diseases and fill an unmet medical need.

The submission was based on data from the ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial, a phase III, randomized, double-blind, placebo-controlled international study of radium-223 with best standard of care (BSC) versus placebo with BSC in symptomatic CRPC patients with bone metastases. The trial enrolled 921 patients in 19 countries. The study treatment consisted of up to six intravenous administrations of radium-223 or placebo each separated by an interval of 4 weeks.

The primary endpoint of the study was overall survival. Secondary endpoints included time to occurrence of skeletal-related events, time to total alkaline phosphatase (ALP) and PSA progression, total ALP response and normalization, safety, and quality of life.