Pfizer/Auxilium’s contracted hand drug set for EU review

Pfizer has been informed by the European Medicines Agency that its marketing application for the biologic Xiaflex, partnered with Auxilium Pharmaceuticals, has been accepted for review as a treatment for Dupuytren’s contracture.

The agency will look at Xiaflex (clostridial collagenase) for the treatment of Dupuytren's contracture, which affects the connective tissue that lies beneath the skin in the palm. Nodules develop in the palm as collagen deposits accumulate and as the disease progresses, the deposits form a cord that stretches from the palm to the base of the finger, causing them to contract.

Currently, surgery is the only effective treatment and primarily affects 3%-6% of the global Caucasian population. Most cases of Dupuytren's contracture occur in patients older than 50 and a hereditary component exists in 40% of those cases.

Armando Anido, Auxilium’s chief executive, said the EMEA’s is “a notable milestone in our effort to bring the first approved minimally-invasive, nonsurgical treatment option to Dupuytren’s contracture patients”. The news has triggered a $15 million milestone payment from Pfizer, which holds the commercial rights to Xiaflex in the European Union and 19 other European and Eurasian countries.

Auxilium is expecting to get the go-ahead for Xiaflex from the US Food and Drug Administration shortly, after the agency’s Arthritis Advisory Committee recommended approval by a unanimous vote of 12 to 0 in September. The compound 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).