Xiaflex sBLA filed with FDA for multiple Dupuytren's contracture-Auxilium Pharma
Auxilium Pharmaceuticals has submitted a supplemental Biologics License Application (sBLA) to the FDA requesting approval of Xiaflex (collagenase clostridium histolyticum), from for the treatment of multiple Dupuytren's contracture (DC) cords concurrently. The sBLA, seeking expansion of the labeling for the concurrent treatment of multiple palpable cords is based on positive results from a global, multicenter Phase IIIb trial, together with data from the Company's earlier MULTICORD studies (AUX-CC-861 and AUX-CC-864). Xiaflex is a biologic approved in the US, EU, Canada and Australia for the treatment of adult DC patients with a palpable cord.
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