Auxilium Pharmaceuticals, Inc. (AUXL) recently announced that data from the pivotal phase III trials, IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies), on Xiaflex, was published online in The Journal of Urology. We note that the IMPRESS trials were conducted to evaluate Xiaflex for Peyronie’s disease (:PD). Both the co-primary and secondary endpoints of the study were achieved. Common adverse events included hematoma, pain and swelling at the treatment site.
Xiaflex is currently under US Food and Drug Administration (:FDA) review for the Peyronie’s indication. A response from the agency should be out by Sep 6, 2013.
Xiaflex is an injectable enzyme that received approval in Feb 2010 from the FDA for the treatment of Dupuytren’s Contracture (:DC), a condition that affects the connective tissue in the palm known as palmar fascia.
Besides the Peyronie’s indication, Xiaflex is being developed for additional indications like the treatment of cellulite and frozen shoulder syndrome.
Pfizer, Inc. (PFE) has marketing rights for Auxilium Pharma’s Xiapex in 46 Eurasian countries through Apr 24, 2013.
In our view, Auxilium Pharma’s chances of gaining approval for the Peyronie’s indication are high. If all goes well, Xiaflex could be in the market for the Peyronie’s indication by late 2013. FDA approval would make Xiaflex the first biologic therapy to be approved for Peyronie’s.
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