CHMP issues positive opinions

The EMEA's CHMP issued positive opinions on MAAs for Preotact recombinant human parathyroid hormone (PTH) from NPS (NPSP) and Nycomed (Roskilde, Denmark) to treat postmenopausal osteoporosis and Evoltra clofarabine from Bioenvision (BIVN) to treat children with refractory or relapsed acute lymphocytic leukemia (ALL). The committee also issued a positive opinion to extend the indication for Erbitux cetuximab from Merck KGaA (FSE:MRK) to include head and neck cancer.

NPSP and Nycomed expect a decision from EMEA next quarter and hope to launch Preotact in the second half. The product is under review with a March 10 PDUFA date in the U.S., where it is called Preos. ...