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FDA approves biologic for Dupuytren's contracture
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The FDA has granted approval for the marketing of collagenase clostridium histolyticum, a biologic product indicated for the treatment of Dupuytren’s contracture in adult patients with a palpable cord.
In a press release, officials for Auxilium Pharmaceuticals Inc.stated that the company expects to begin shipping collagenase clostridium histolyticum (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,” Armando Anido, Chief Executive Officer and President of Auxilium, stated in the press release. “Xiaflex is the only FDA-approved nonsurgical medical treatment for Dupuytren’s contracture.”
In September 2009, the FDA Arthritis Drugs Advisory Committee panel voted 12-0 to recommend the agency approve the novel, first-in-class, orphan-designated biologic.
New standard?
“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,” Larry Hurst, MD, a study investigator and chairman of the department of orthopedics at SUNY in Stony Brook, N.Y., stated in the release,
“I believe that Xiaflex, as a new nonsurgical treatment, could potentially become the standard of care for Dupuytren's contracture,” he noted.
FDA requirements
The FDA has required that the company complete a risk evaluation and mitigation strategy program for Xiaflex. The program must consist of a communication plan and a medication guide to deal with known and potential risks and serious adverse events. In addition, it must inform healthcare providers about proper injection and other techniques, and inform patients about the serious risks associated with the product.
Auxilium plans to market the biologic to physicians experienced in injection procedures of the hand and treatment of Dupuytren’s contracture. The company will only provide access to the biologic after physicians have completed a training program, according to the release.
Auxilium licenses collagenase clostridium histolyticum from BioSpecifics, Lynbrook, N.Y.
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