FDA Approves Drug Discovered By Stony Brook Orthopaedic Researchers For Debilitating Hand Disorder Affecting Millions

The U.S. Food and Drug Administration (FDA) has approved Xiaflex, a new drug to treat Dupuytren’s contracture (or disease) that was discovered and developed by Marie A. Badalamente, Ph.D., and Lawrence C. Hurst, M.D., in the Department of Orthopaedics at Stony Brook University Medical Center. Dupuytren’s contracture is a debilitating hand disorder caused by progressive accumulation of collagen that deforms fingers and limits motion and affects millions worldwide. The new treatment is the first FDA-approved non-surgical treatment for Dupuytren’s contracture. Previous FDA-approved clinical trials of the drug, an injectable form of the enzyme, collagenase, showed that it significantly improves outcomes in patients with the disease.

The February 2, 2010, FDA approval comes after months of review of Xiaflex, which will be manufactured by Auxilium Pharmaceuticals, Inc., based in Malvern, Penn. Shortly after Drs. Badalamente and Hurst published their study results on the use of the collagenase treatment for Dupuytren’s contracture in The New England Journal of Medicine on September 3, 2009, an FDA advisory panel had voted unanimously (12-0) to recommend the drug as a treatment to combat the hand disorder. Auxilium is moving forward to launch marketing and production of Xiaflex, which is expected to be available to orthopedic surgeons and hand specialists in March.

“The FDA decision is a monumental one in that patients with Dupuytren’s contracture will now have an alternative treatment that does not require surgery and has been shown in clinical trials to be very effective,” says Dr. Hurst, Co-Principal Investigator and Professor and Chair of the SBUMC Department of Orthopaedics, who indicates that hundreds of patients with the hand disorder have already contacted him about the treatment in recent weeks.

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