Peyronie's disease, commonly known as PD, is a physically and
potentially emotionally devastating disorder in men that can result in
varying degrees of penile curvature deformity. If approved by the U.S. Food and Drug Administration, Xiaflex is
expected to be the first and only approved-biologic-therapy for the
treatment of PD in modern medicine. It is very exiting news for Peyronie's patients, scientists note.
Other common treatments, such as oral, topical and injection
therapies, are non-FDA-approved and not based on rigorous scientific
data, Auxilium said. As of now, surgery is typically a last resort
treatment, as it often carries a large risk of complications, including
decreased penile length or erectile dysfunction.
The Malvern, Pa.-based company said the drug, Xiaflex, met statistically significant endpoints in two 52-week studies. In the first, the drug reported a 37.6% mean reduction in penile
curvature deformity and a 44% improvement in disease bother. In the
second, deformity reduced by 30.5%, while bother improved by 32.4%.
The drug was generally well-tolerated, with the only adverse events
related to pain and swelling at the injection site, Auxilium said. "We believe that Xiaflex, if approved for the treatment of Peyronie's
Disease, has the clinical profile to become a potential breakthrough
procedure," Auxilium chief executive, Adrian Adams, said in a statement. Reflecting Auxilium's view that Xiaflex could be a pipeline drug with
?potential applications in multiple therapeutic areas that currently
have limited options,? brokerage RBC raised its price target on Auxilium
to $28 from $26 on an ?outperform? rating.
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