Auxilium Pharmaceuticals, Inc. has announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for Xiaflex (collagenase clostridium histolyticum), a novel, 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 Xiaflex 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. "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."

The Company will market and sell Xiaflex in the United States through a team of approximately 100 field sales managers and representatives, reimbursement specialists and managed market account directors. In addition, a staff of 11 highly trained medical science liaisons will provide medical support for Xiaflex. The Company has established a distribution network that 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. For information and questions on Xiaflex, patients and physicians can contact Auxilium at 1-877-Xiaflex.

"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."

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 to evaluate and mitigate known and potential risks and serious adverse events; to inform healthcare providers about how to properly inject Xiaflex and perform finger extension procedures; and, to inform patients about the serious risks associated with Xiaflex. Auxilium plans to market Xiaflex to physicians who are experienced in injection procedures of the hand and treatment of Dupuytren's contracture and will only provide access to Xiaflex after physicians have attested to completion of a training program. The training program is available as a video or written manual and demonstrates proper use and administration of Xiaflex, as well as an overview of both identified and potential risks with Xiaflex.

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