Auxilium Pharmaceuticals says that US regulators have granted approval for its biologic Xiaflex for Dupuytren’s contracture, which has previously been treated only through surgery.

The US Food and Drug Administration has given the green light for Xiaflex (clostridial collagenase histolyticum) to treat the condition that affects the connective tissue that lies beneath the skin in the palm. As the disease progresses, collagen deposits form a cord that stretches from the palm to the base of the finger, causing them to contract.

Auxilium will start selling Xiaflex in the USA by the end of March through a 100-field force, supported by a staff of “11 highly trained medical science liaisons”. The FDA has required the company to put together a risk evaluation and mitigation strategy programme designed primarily to inform healthcare providers about how to properly inject the treatment and perform finger extension procedures, plus inform patients about the risks associated.

The agency noted that common side effects reported in clinical trials were fluid buildup, swelling and pain and bruising in the injected area, However, Bob Rappaport, director of the Division of Anesthesia, Analgesia and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, noted that “since there are no other nonsurgical alternatives for Dupuytren's contracture, Xiaflex will be an important advance in the management of this disabling condition”.

The US approval comes a couple of weeks after Auxilium’s partner Pfizer had its marketing application for Xiaflex accepted by the European Medicines Agency, triggering a $15 million milestone payment. The drug is also in Phase IIb for the treatment of Peyronie's disease, which involves the development of collagen plaque, or scar tissue, on the shaft of the penis that hardens and reduces flexibility, and in Phase II for frozen shoulder syndrome (adhesive capsulitis).