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.