Wyeth says European Union committee gives positive opinion on Prevenar-13 vaccine
By APFriday, September 25, 2009
Wyeth says committee recommends Prevenar-13 OK
NEW YORK — Wyeth says European Union regulators are recommending approval for a new version of its children’s pneumococcal vaccine, Prevenar 13.
The Madison, N.J., company says 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 viruses.
A final decision from the European Medicines Agency is expected in the coming months, the company says.
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 is expected to make a ruling by Dec. 30.
The original Prevnar is Wyeth’s second best-selling drug, with $2.7 billion in revenue in 2008.
