HPV Vaccine In-Waiting
Glaxo, still struggling to overcome the Avandia diabetes pill controversy and subsequent lost revenue, has been dealt another blow by the FDA. The agency has issued a “complete response letter” to Glaxo for its Cervarix vaccine. It is unclear whether the FDA will require additional clinical trials for Cervarix. The unexpected delay in approval could last as little as six-months or as long as two-years.
“We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses,” says Barbara Howe, VP and Director for Glaxo’s North American vaccine development, says in a statement. “Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring CERVARIX the U.S. market.
Cervarix is one of Glaxo’s biggest new meds and is already approved in 45 countries, including the European Union. The US market remains its most important battleground, where the drugmaker already trails Merck and its Gardasil vaccine for the human papillomavirus that leads to cervical cancer. Gardasil targets four strains of HPV – including two causing cancer and two causing genital warts, while Cervarix targets only the two cancer strains.
What we don’t want, is the FDA saying. we want to see new data because that would potentially add in one to two years, Navid Malik, an analyst at Collins Stewart in London, tells Bloomberg News. It would be disappointing if the delay was substantial, but it could be something like a six-month delay if the FDA only wants relatively minor information.
