FDA upbeat on Glaxo, Merck HPV vaccines
WASHINGTON - Federal regulators said yesterday a GlaxoSmithKline vaccine prevents the leading cause of cervical cancer in women, bringing the company one step closer to competing with Merck’s blockbuster Gardasil.
In documents posted online, the Food and Drug Administration said Cervarix - Glaxo’s vaccine against human papilloma virus, or HPV - successfully blocked the two leading strains of the virus nearly 93 percent of the time.
But even as the British drug maker moves closer to competing in the United States, Merck is poised to begin marketing Gardasil to boys and men. In a separate review, the FDA said that vaccine prevented genital warts in males 90 percent of the time.
The agency will ask a panel of vaccine experts next week to weigh in on both vaccines.
While Merck has suggested the approval for boys could double the potential market for Gardasil, Leerink Swann analyst Seamus Fernandez said the benefit likely will be minimal.
Glaxo has won a number of government contracts for Cervarix in Europe, but its US launch was delayed in 2007 when the FDA said it needed more data about the vaccine.
