Auxilium Pharmaceuticals’ Xiaflex Approved by FDA
The US Food and Drug Administration (FDA) announced on Friday that they have approved Auxilium Pharmaceuticals’ Xiaflex to treat Peyronie’s disease, which causes painful, curved erections in men.
Xiaflex (collagenase clostridium histolyticum) is the first FDA-approved non-surgical treatment option for men with Peyronie’s disease, who have a plaque in the penis that results in curvature deformity of at least 30 degrees upon erection. Peyronie’s is caused by scar tissue that develops under the skin of the penis.
According to Auxilium Pharmaceuticals, between three and nine percent of US men are affected by a disease which is believed to often go undiagnosed.
The regulatory approval for the drug is based on two clinical studies involving 832 men with Peyronie’s who were given up to four treatment cycles of Xiaflex or placebo and were then monitored for 52 weeks. The data highlighted that Xiaflex considerably reduces penile curvature deformity, and related bothersome effects, in comparison to the placebo.
The US regulatory body emphasised that Xiaflex is only available through a restricted programme as a result of the risks of serious adverse reactions, including penile fracture. As part of the conditions of the drug approval, healthcare professionals must enrol and complete a training program in order to prescribe the drug.
Martin Gelbard from the UCLA School of Medicine commented that treating Peyronie’s “has been a challenge as, until now, we have had few options to offer our patients,” so the regulatory approval is “a significant achievement” to help doctors deal with “this physically and psychologically devastating disorder.”
Xiaflex is also approved for Dupuytren’s contracture, a condition that affects the connective tissue beneath the skin in the palm of the hand.