WASHINGTON - Drugmaker Merck likely will face U.S. competition for its vaccine Gardasil, after federal experts recommended rival GlaxoSmithKline's Cervarix also be approved to prevent the virus that causes most cervical cancers.
The FDA's panel of vaccine experts voted overwhelmingly Wednesday that Cervarix appears safe and effective for girls and women ages 10 to 25. If the FDA follows the group's advice as it usually does, Glaxo would begin competing against Merck's Gardasil, which has controlled the U.S. market since 2006.
But Merck won its own small victory at the meeting, as the same panel recommended Gardasil be expanded to prevent genital warts in males aged 9 to 26, a new use for a vaccine that already posts sales of more than $1 billion.
Last year nearly 4,000 women died of cervical cancer in the United States, less than 1 percent of all cancer-related deaths.
London-based drugmaker Glaxo already has won approval for Cervarix in Europe, but its U.S. launch was delayed in 2007 when the FDA said it needed more data.