ARTICLE | Regulation
Rotavirus showdown
February 25, 2008 8:00 AM UTC
An FDA advisory panel's endorsement last week of Rotarix, developed by Avant Immunotherapeutics Inc. and GlaxoSmithKline plc, sets the stage for a rivalry with Merck & Co. Inc., which has had the U.S. rotavirus vaccine market to itself since it received FDA approval for its RotaTeq vaccine in 2006.
The Vaccines and Related Biological Products Advisory Committee's unanimous vote that GSK demonstrated Rotarix's efficacy, and the panel's 11-1 vote that the data demonstrate its safety, make FDA approval likely. The BLA has an April 3 PDUFA deadline. ...