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Auxilium Submits Xiafelx BLA

Auxilium Pharmaceuticals, Inc. has submitted a BLA to the FDA for Xiaflex (clostridial collagenase for injection), a novel orphan-designated biologic for the treatment of Dupuytren's contracture.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Auxilium Pharmaceuticals, Inc. has submitted a BLA to the FDA for Xiaflex (clostridial collagenase for injection), a novel orphan-designated biologic for the treatment of Dupuytren’s contracture.

“This BLA submission is a significant regulatory milestone for Xiaflex,” said Armando Anido, chief executive officer and president of Auxilium. “There currently are no approved non-surgical treatments available for Dupuytren’s contracture, which can be a debilitating disease that often affects patients’ quality of life. We believe that Xiaflex, if approved, would be the non-surgical treatment choice for the management of Dupuytren’s contracture and could meaningfully improve the lives of patients diagnosed with the disease.”

The BLA is based on data from 1082 patients with Dupuytren’s contracture treated with more than 2600 injections of Xiaflex. Auxilium has requested Priority Review designation for this BLA and expects a response from the FDA within 60 days of the filing date. If granted, the FDA has six months from submission date to take action. Priority Review may be granted to drugs that provide treatment for a disease for which no approved treatments exist.

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