The U.S. Food and Drug Administration’s approval of Auxilium Pharmaceuticals’ drug Xiaflex (NASDAQ: AUXL) makes it the first medication to treat Peyronie’s disease. It is a painful condition affecting the penis and the drug could lead to more people seeking treatment.
Peyronie’s disease is a connective tissue disorder that results in the growth of fibrous plaque in the soft tissue of the penis. The condition can cause pain, abnormal curvature and erectile dysfunction, among other symptoms. It can also be associated with diabetes.
The approval for the Philadelphia area company’s drug creates a potentially cheaper alternative to surgery for the estimated 1 percent to 3 percent of men with the disease. The embarrassment associated with the condition means the number of people with the condition could be much higher.
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Data from a study published in the Journal of Urology showed the drug improved penile curvature by 37 percent compared with 18 percent for participants on a placebo.
Auxilium’s drug requires a series of eight injections in areas where the plaque is located.
The condition can go away on its own and doctors may recommend not doing anything unless the condition worsens, according to WebMD. Still, surgery has been the only option to treat the condition and the outcomes can vary.
Xiaflex was initially approved as a treatment for a hand condition in which collagen builds up and prevents fingers from straightening, according to Bloomberg. The drug generated $55 million in U.S. sales in 2012.
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The approval is also good news for the company’s licensing deal for the drug with Swiss pharma company, Actelion. The $68.5 million deal covers Peyronie’s disease and Dupuytren’s contracture and includes Canada, Brazil, Australia and Mexico.
