FDA Approves Biologic for Debilitating Hand Disease

Yael Waknine

February 03, 2010

February 3, 2010 — The US Food and Drug Administration (FDA) has approved collagenase clostridium histolyticum injection (Xiaflex, Auxilium Pharmaceuticals, Inc) as the first treatment for a progressive hand disease known as Dupuytren's contracture. The company expects to launch the first-in-class, orphan-designated biologic in late March 2010.

Dupuytren's is a debilitating condition caused by an abnormal buildup of collagen in the connective tissue of the palms and hands, forming thick rope-like cords that cause the fingers to curl. As the contractures increase, it may be difficult to use affected fingers to grasp objects. The condition affects an estimated 240,000 individuals across the United States and Europe and is most common among whites and men older than 50 years.

"Before the FDA approved Xiaflex, the only effective treatment for this hand disorder was surgery, which sometimes meant a long recovery and the need for physical therapy for patients," said Bob Rappaport, MD, director, Division of Anesthesiology, Analgesia, and Rheumatology of the FDA's Center for Drug Evaluation and Research, in an agency news release. "Since there are no other non-surgical alternatives for Dupuytren's contracture, Xiaflex will be an important advance in the management of this disabling condition."

The product, which contains 2 microbial collagenases derived from Clostridium histolyticum bacteria, is administered intralesionally into affected areas of the hand to soften and ultimately lyse the cords, restoring flexibility.

Its approval was based in part on data from a 306-patient study, showing that 64% of those treated with the biologic achieved finger mobility compared with 7% of those receiving placebo. In a smaller study (n = 66), the success rate was 44% (vs 5% for placebo).

Adverse events most commonly reported in the studies (incidence ≥ 25%) included peripheral edema, contusion, injection-site reaction, injection-site hemorrhage, and pain in the injected extremity. Although no serious allergic reactions were observed, the presence of foreign proteins poses a risk for immune response.

"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, MD, study investigator and professor and chair, Department of Orthopedics at State University of New York Stony Brook in a company news release. "I believe that Xiaflex, as a new nonsurgical treatment, could potentially become the standard of care for Dupuytren's contracture."

Because of the potential for tendon ruptures, the FDA is requiring implementation of a risk evaluation and mitigation strategy program that will inform clinicians about how to properly perform injections and finger extensions. Access to the collagenase product will be limited to clinicians who have completed the training program, which can be obtained as a video or written manual by calling 1-877-XIAFLEX.

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