(By Balachander) Auxilium Pharmaceuticals Inc. (NASDAQ: AUXL) said the U.S. health regulators have accepted for filing and granted standard review status to its supplemental Biologics License Application (sBLA) for XIAFLEX for the potential treatment of Peyronie's disease (PD).
The Malvern, Pennsylvania-based company expects the U.S. Food and Drug Administration (FDA) to take action on the application by September 6, 2013.
XIAFLEX is currently approved in the U.S., EU, Canada and Switzerland to treat adult Dupuytren's contracture patients with a palpable cord. XIAFLEX for the treatment of PD was granted orphan designation in the U.S. by the FDA in January 1996 and, if approved by the FDA, is expected to be the first and only biologic therapy indicated for the treatment of PD.
[Related -Three Stocks Set For FDA News In Early December]
PD is the development of collagen plaque, or scar tissue, on the shaft of the penis that may harden and reduce flexibility, causing the penis to deform in a bend or arc during erection.
In a two identical late-stage double-blind placebo-controlled IMPRESS studies, the company said ,XIAFLEX demonstrated statistically significant improvement in the co-primary endpoints of penile curvature deformity and patient-reported bother versus placebo. Serious adverse events included corporal rupture (penile fracture) in 3 subjects in the placebo controlled studies.
The stock, which has been trading in the 52-week range of $16.98 to $29.37, ended at $18.33 on Wednesday.