• Thursday, February 18th, 2010

Stay out of the OR with XIAFLEX…the biologics veterans at Auxilium Pharmaceuticals, Inc. have announced that the company has received marketing approval from the FDA for XIAFLEX (collagenase clostridium histolyticum) for the treatment of adult Dupuytren’s contracture patients with a palpable cord. In this condition, knots of connective tissue form under the skin and render normal hand functioning difficult. Auxilium expects to begin shipping XIAFLEX, a novel, first-in-class, orphan-designated, biologic, to its distribution partners in early March in advance of a launch planned for late March.

“We believe the approval of XIAFLEX represents a major breakthrough for patients suffering from the debilitating effects of Dupuytren’s contracture,” said Armando Anido, CEO and President of Auxilium, in the news release. “XIAFLEX is the first and only FDA-approved nonsurgical 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.”

Auxilium will market and sell XIAFLEX in the US through approximately 100 field sales managers and representatives, reimbursement specialists and managed market account directors. Also, eleven highly trained medical science liaisons will provide medical support for XIAFLEX. A new distribution network will allow health care providers to access XIAFLEX through specialty distributors and specialty pharmacies or in the institutional setting after they have undergone training on XIAFLEX and its administration.

“With the safety and effectiveness of XIAFLEX demonstrated across multiple clinical trials, physicians can now use XIAFLEX to treat any symptomatic cords in patients with Dupuytren’s contracture,” said Larry Hurst, M.D., study investigator and Professor and Chair, Department of Orthopaedics at SUNY Stony Brook. “I believe that XIAFLEX, as a new nonsurgical treatment, could potentially become the standard of care for Dupuytren’s contracture.”

The FDA has required a risk evaluation and mitigation strategy (REMS) program for XIAFLEX, which consists of a communication plan and a medication guide. This REMS is designed (1) to evaluate and mitigate known and potential risks and serious adverse events; (2) to inform healthcare providers about how to properly inject XIAFLEX and perform finger extension procedures; and, (3) to inform patients about the serious risks associated with XIAFLEX.

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