FDA Approved Xiaflex for Dupuytren's at Meeting Today
The U.S. Food and Drug Administration Advisory Panel meet today, September 16, to review the data on Xiaflex and its use for Dupytren’s Disease. The panel of outside experts voted 12-0 in favor of Xiaflex.
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 of clostridial collagenase which can been done in the office.
Xiaflex is a form of clostridial collagenase that aims to loosen collagen deposits in the hand that can form into hard nodules and tight cords. Treatment for milder cases can involve physical therapy, though many doctors call for careful observation.
Panel members reviewed studies like the one recently 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 panel voiced concerns regarding long-term effects and whether the disease might reoccur over time as it does in some patients who undergo surgery.
They were also divided over who should administer the injections. Auxilium has intentions 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. The panel was divided on limited the use of Xiaflex in severe cases be limited to surgeons who specialize in the hand or whether it should be more widely available from other doctors.
The most commonly reported adverse events were localized swelling, pain, bruising, pruritus, and transient regional lymph-node enlargement and tenderness. Serious adverse events have been rare, but include tendon ruptures and complex regional pain syndrome.
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 e