FDA arthritis drug panel unanimously recommends approval of first biologic treatment for Dupuytren’s contracture

The Food and Drug Administration Arthritis Drugs Advisory Committee panel voted 12-0 on Wednesday in favor of granting marketing approval for clostridial collagenase in the proposed treatment of Dupuytren’s disease, a hand condition affecting 3% to 5% of Caucasians that is characterized by thickened and scarred tendons that can restrict hand movement.

Auxilium Pharmaceuticals Inc., of Malvern, Penn., submitted to the FDA for priority review its biologics license application 125338, which sought to allow a 0.58 mg injection of collagenase clostridium histolyticum (XIAFLEX) into an affected cord of the metacarpophalangeal or proximal interphalangeal joint up to three times at 4-week intervals, with the possibility of treating other cords if needed.

“We are very pleased with the advisory committee’s unanimous recommendation, which supports our view that XIAFLEX has a favorable benefit to risk profile in the treatment of Dupuytren’s contracture,” Armando Anido, Auxilium chief executive officer and president, stated in a press release his company issued. “XIAFLEX has the potential to provide an important new non-surgical treatment option for patients with Dupuytren’s contracture, a debilitating hand condition severely affecting patients’ quality of life,” he said.

Auxilium licenses collagenase clostridium histolyticum from BioSpecifics, Lynbrook, N.Y.

If the FDA agrees with the panel’s favorable vote, with priority review marketing approval could be granted within 6 months.

In addition to the regular rheumatology and pain management specialist members of the Arthritis Advisory Committee, temporary voting members on the panel included orthopedic surgeons and hand and plastic surgery specialists.

Currently no FDA-approved drugs or nonsurgical approaches are indicated for Dupuytren’s disease, leaving open surgical procedures as the only approved treatment for now.

Auxilium submitted to the FDA results of more than 2,600 injections performed in 1,082 patients during three double-blind, placebo-controlled studies.

“The data presented in this application demonstrate that [collagenase clostridium histolyticum] significantly reduces contracture caused by advanced Dupuytren’s disease, which would have otherwise required surgical intervention,” company officials wrote in a briefing submitted for the meeting.

According to the briefing, the drug uses enzymes to break up the cords. It would be administered in a physician’s office followed by a finger extension procedure and is well tolerated. The majority of adverse events reported were local to the treated extremity and mild to moderately severe. Of the 830 cords studied that were successfully treated with collagenase clostridium histolyticum, 30 joint contractures to 20· recurred during the 12-month follow-up for an estimated 6.7% rate of recurrence, according to the Kaplan-Meier estimate.

Reference:
Hurst LC, Badalamente MA, Hentz VR, et al. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009;361(10):968-979.