NEW YORK and MALVERN, Pennsylvania, December 16, 2010 /PRNewswire/ -- Pfizer Inc. has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending European Union (EU) approval for XIAPEX(R) (collagenase clostridium histolyticum) as treatment for Dupuytren's contracture in adult patients with a palpable cord.(1) Collagenase clostridium histolyticum is the first injectable treatment to be recommended for approval in the EU for the treatment of Dupuytren's contracture, a condition that has been primarily treated by invasive surgical therapies. Pfizer has the marketing rights to collagenase clostridium histolyticum in Europe and Auxilium Pharmaceuticals Inc. has the rights in the rest of the world.

The CHMP's positive recommendation will be reviewed by the European Commission, which has authority to approve medicines for the European Union. Pfizer anticipates a final decision from the European Commission by the end of the first quarter of 2011. The positive CHMP opinion is based on results from two pivotal studies, Collagenase Option for Reduction of Dupuytren's (CORD I and CORD II).(2,3)

Dupuytren's disease affects up to 13% of the European population.(4-7) It is a slowly progressive condition affecting the connective tissue in the palm of the hand and the fingers.(8) Early in the disease, the formation of nodules leads to an increase in collagen deposits, and later the formation of pathological cords, which cause debilitating joint contractures and fixed-flexion deformities (where the finger is permanently bent inwards into the palm of the hand), known as Dupuytren's contracture.(8) Once contracture has occurred, the affected finger often impacts on the ability to carry out everyday tasks.(8)

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