Auxilium drug approved for Peyronie’s Disease

In Regulation & Government by Tim Peplow


Auxilium Pharmaceuticals has announced that its orphan drug Xiaflex has been approved by the FDA for the treatment of Peyronie’s disease, a condition that causes the penis to arch during erection due to scar tissue formation on the shaft. Of course, it’s a condition that’s debilitating not only physically but also psychologically, with patients having concerns about appearance, pain, and impact on intercourse.

It’s thought that between 65,000 and 120,000 patients are diagnosed in the US each year. With up to 6,500 treated each year with injectables or surgery, the disease is also thought to be undertreated.

Xiaflex, a biologic medicine also known as collagenase clostridium histolyticum, is the first FDA-approved drug for the condition. Believed to work by breaking down the build-up of collagen which leads to the deformity, the drug’s approval was based on the IMPRESS trials, which showed that the drug was effective both in terms of reducing penile curvature deformity and disease “bother”.

Xiaflex is already available in the US, EU, Canada and Australia as a treatment for Dupuytren’s contracture.

Read the press release from Auxilium and the FDA >