(Reuters) - U.S. health regulators on Friday approved Auxilium Pharmaceuticals Inc's Xiaflex injections to treat a condition that causes a painful curvature of the penis called Peyronie's disease.
It marks the second U.S. approval for Xiaflex, which in 2010 received a Food and Drug Administration nod to treat Dupuytren's contracture - a condition in which hardening of the connective tissue collagen in the hands bends fingers toward the palm, leaving a patient unable to straighten their hand or use their fingers properly.
Auxilium shares were up more than 9 percent at $21.13 in afternoon trading on Nasdaq.
Xiaflex is now the first FDA-approved non-surgical treatment option for men with Peyronie's disease who have a plaque buildup in the penis that results in a curvature deformity of at least 30 degrees upon erection, the agency said.
The drug is injected directly into the collagen buildup to break it down in order to help restore normal function to the penis or hands.
Cowen and Co is forecasting that Peyronie's approval will add $100 million to annual Xiaflex sales by 2018.
Treatment for Peyronie's would consist of a maximum of four treatment cycles, the FDA said. Each treatment cycle consists of two Xiaflex injections directly into the collagen-containing structure of the penis, and one penile modeling procedure - a massaging of the treated area by a health care professional to help further break down the plaque or scar tissue.
In clinical trials, Xiaflex significantly reduced penile curvature deformity and related bothersome effects compared with a placebo, the FDA said.
A potential serious side effect of treatment with Xiaflex is penile fracture - a rupture within the penile shaft. As a result, a condition of the approval is the implementation of a Risk Evaluation and Mitigation Strategy (REMS).
The REMS requires participating health care professionals to be certified by completing training in the administration of Xiaflex for Peyronie's disease. The REMS also requires health care facilities to ensure that Xiaflex is dispensed only for use by certified health care professionals, the FDA said.
The most common adverse reactions associated with Xiaflex for Peyronie's treatment include penile bruising, swelling and pain.
(Reporting by Bill Berkrot; editing by Andrew Hay)
- Pharmaceuticals & Drug Trials
- Food and Drug Administration