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EU Regulators Backing Wyeth Vaccine

By Drug Discovery Trends Editor | September 28, 2009

NEW YORK (AP) – Wyeth said Friday European Union regulators are recommending approval for a new version of its children’s pneumococcal vaccine, Prevenar 13.

The Madison, N.J., company said the Committee for Medicinal Products for Human Use recommended approval in children 6 weeks to 5 years to prevent pneumococcal disease, as well as pneumonia and middle ear infections caused by related strains of the bacterium. Pneumococcal disease can also cause meningitis and blood infections.

A final decision from the European Medicines Agency is expected in the coming months, the company said.

The original vaccine is Wyeth’s second best-selling drug, with $2.7 billion in revenue in 2008. The original protects against seven types of disease, the new version includes six more.

Wyeth, which is being bought by Pfizer for $68 billion, is seeking U.S. approval for the drug under the name Prevnar 13. The FDA, which delayed its decision last month, is expected to make a ruling by Dec. 30.

Wyeth shares slipped 20 cents to $47.86.

Date: September 25, 2009
Source: Associated Press


Filed Under: Drug Discovery

 

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