Friday, June 22, 2012

Reuters: Regulatory News: UPDATE 1-Novartis, Astra win EU drug okays; Pfizer loses out

Reuters: Regulatory News
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UPDATE 1-Novartis, Astra win EU drug okays; Pfizer loses out
Jun 22nd 2012, 11:51

Fri Jun 22, 2012 7:51am EDT

LONDON, June 22 (Reuters) - Novartis and AstraZeneca won recommendations for important new drugs from European regulators on Friday, while rival Pfizer lost out.

The European Medicines Agency said its Committee for Medicinal Products for Human Use (CHMP) had endorsed Novartis's Afinitor for treating breast cancer in addition to other tumour types. It also okayed AstraZeneca's new antibiotic Zinforo.

AstraZeneca secured rights to the antibiotic, also known as ceftaroline, outside North America and Japan from Forest Laboratories in 2009.

Pfizer, however, failed to secure backing for Elelyso, a new treatment for Gaucher disease that was approved in the United States in May.

The London-based agency also recommended another drug from Novartis for lung disease, known as Enurev Breezhaler or glycopyrronium, as well as Revestive from Takeda's Nycomed unit for short bowel syndrome.

Recommendations for marketing approval by the CHMP are normally endorsed by the European Commission within a couple of months.

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