FDA Expands Dupuytren's Contracture Use for Xiaflex

Larry Hand

Disclosures

October 21, 2014

The US Food and Drug Administration (FDA) has expanded the approval of collagenase clostridium histolyticum (HCC; Xiaflex, Auxillium Pharmaceuticals) for the treatment of up to two Dupuytren's contracture (DC) joints in the same hand during a single treatment visit, according to the company.

The action was a supplemental approval for HCC, which is already approved in the United States, the European Union, Canada, and Australia for the treatment of adult patients with DC with a palpable cord. HCC is also approved in the United States for Peyronie's disease.

A progressive condition affecting the tissue just under the skin of the palm of the hand, DC increases the amount of collagen produced. The build-up worsens over time, eventually leading to rope-like collagen cords that thicken and shorten and cause the fingers to be drawn toward the palm.

The Auxillium supplemental biologics application was based on results of a phase 3b clinical trial in which researchers found that two concurrent HCC injections were safely used to treat one hand with multiple affected joints. A finger extension procedure can be done at 24, 48, or 72 hours after injection.

"In my opinion, Xiaflex provides an effective non-surgical option for treating DC patients with two affected joints concurrently in one office visit," Gary M. Pess, MD, an orthopedic hand surgeon with Central Jersey Hand Surgery, said in a news release. "In my practice, the expanded labeling will also allow flexibility in the scheduling process due to the ability to delay the finger manipulation procedure from 24 to up to 72 hours, which may be more convenient for patients."

HCC can cause some adverse effects, including tendon rupture or ligament damage, hypersensitivity reactions, and increased chance of bleeding. Persons who have had an allergic reaction to collagen clostridium histolyticum or any ingredients in HCC should not receive the drug, according to the company.

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