Auxilium Pharmaceuticals, Inc. (AUXL) Thursday said its supplemental Biologics License Application, or sBLA, for XIAFLEX has been accepted by the U.S. Food and Drug Administration.
Xiaflex is a novel biologic therapy for the potential treatment of Peyronie's disease. XIAFLEX is currently approved in the U.S., EU, Canada and Switzerland for the treatment of adult Dupuytren's contracture patients with a palpable cord. In 1996, XIAFLEX was granted orphan drug status in the U.S.
The sBLA includes data from the clinical study, named by the acronym, IMPRESS - The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies - and other controlled and uncontrolled clinical studies
In the two identical phase III double-blind placebo-controlled IMPRESS studies, over 1,000 PD patients received over 7,400 injections of XIAFLEX. XIAFLEX showed significant improvement in the co-primary endpoints of penile curvature deformity and patient-reported bother versus placebo.
There is need for a safe and effective treatment with proven results for patients with classic penile curvature deformity and patient-reported bother associated with Peyronie's disease, said Adrian Adams, CEO and President of Auxilium.
The FDA is expected to take action on the application by September 6, 2013.
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