Auxilium Gains Approval for Xiaflex

Auxilium Pharmaceuticals has received marketing approval from the FDA for Xiaflex (collagenase clostridium histolyticum), a first in class, orphan-designated, biologic for the treatment of adult Dupuytren’s contracture patients with a palpable cord. The company expects to begin shipping the drug to its distribution partners in early March for the planned launch in late March.

Auxilium will market Xiaflex in the U.S. and has established a distribution network that will allow health care providers to access the drug through specialty distributors and specialty pharmacies.

“We believe the approval of Xiaflex represents a major breakthrough for patients suffering from the debilitating effects of Dupuytren’s contracture,” said Armando Anido, chief executive officer and president of Auxilium. “Xiaflex is the only FDA-approved nonsurgical medical treatment for Dupuytren’s contracture. I want to thank the employees of Auxilium and all of the clinical investigators who worked so hard to make this breakthrough a reality.”

FDA has required a risk evaluation and mitigation strategy (REMS) program for the drug, which consists of a communication plan and a medication guide designed to evaluate and mitigate known and potential risks and serious adverse events.