FDA To Review Xiaflex for Dupuytren's Disease On Wednesday
The U.S. Food and Drug Administration Advisory Panel will meet this Wednesday, September 16, to review the data on Xiaflex and its use for Dupuytren's Disease.
Dupuytren's contracture is an abnormal thickening of tough tissue (fibrous layer) underneath the skin of the palm and fingers. It is the thickening of this tissue that can cause the fingers to curl. It can be disabling. Until now there has been no treatment other than surgery. Xiaflex is an injection which can been done in the office.
A recent study published in the New England Journal of Medicine which looked at 308 patients with joint contractures of 20 degrees or more in a prospective, randomized, double-blind, placebo-controlled, multicenter trial showed significant improvement. More cords that were injected with collagenase than cords injected with placebo met the primary end point (64.0% vs. 6.8%). Overall, the range of motion in the joints was significantly improved after injection with collagenase as compared with placebo (from 43.9 to 80.7 degrees vs. from 45.3 to 49.5 degrees).
The most commonly reported adverse events were localized swelling, pain, bruising, pruritus, and transient regional lymph-node enlargement and tenderness. Three treatment-related serious adverse events were reported: two tendon ruptures and one case of complex regional pain syndrome.
Auxilium, a specialty biotech company, is seeking FDA approval of Xiaflex (collagenase clostridium histolyticum) to treat the early forms of Dupuytren’s using an injection of Xiaflex. , an office-based, nonsurgical option, may reduce joint contractures caused by Dupuytren's disease.
Auxilium intends to market the drug for use not only by hand, orthopedic and other surgeons but also to rheumatologists, nonsurgeons who specialize in arthritis and other joint issues. Physicians would be trained with a video and a training manual, Auxilium said.
FDA News Release
American Academy of Orthopedic Surgeons
Injectable collagenase clostridium histolyticum for Dupuytren's contracture. ; N Engl J Med 361:968 (2009); Lawrence C Hurst et al.