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09-05-2009, 12:08 PM #1
FDA calls Glaxo vaccine effective
FDA calls Glaxo vaccine effective
WASHINGTON — Federal regulators said yesterday that 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, which has controlled the U.S. market for three years.
In documents posted online, the Food and Drug Administration said Cervarix — Glaxo's vaccine against human papilloma virus — successfully blocked the two leading strains of HPV nearly 93 percent of the time.
But even as the British drugmaker moves closer to competing in the United States, Merck is poised to begin marketing Gardasil to boys and men. 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. The FDA isn't required to follow the group's advice but usually does.
Associated Press
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