XIAPEX (Collagenase Clostridium Histolyticum) Receives Positive CHMP Opinion
Collagenase Clostridium Histolyticum Recommended for Approval in the European Union (EU) for the Treatment of Dupuytren's Contracture in Adult Patients with a Palpable Cord
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® (collagenase clostridium histolyticum) as treatment for Dupuytren's contracture in adult patients with a palpable cord. 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. (Nasdaq: AUXL) 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).
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