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
