It may only be a matter of a few months. That’s because Glaxo may launch Cervarix this year if it gets accelerated review by the FDA. The agency could decide this month to grant Glaxo’s vaccine a faster priority review, which could potentially prompt approval and sale by the end of this year, saysof the product by the end of 2007, Jim Tursi, Glaxo’s director of medical affairs for Cervarix, told a medical meeting in San Diego.

Generally, the FDA grants priority review to products that serve unmet medical needs. And the agency takes about six months to review drugs granted priority designation, compared with at least 10 months for standard review. Glaxo filed for FDA approval in March, nine months after Merck won approval for Gardasil. Glaxo’s vaccine is supposedly displaying more effectiveness in tests, but that’s not the same thing as saying Cervarix serves and an unmet need.

Source: Bloomberg News
[tags]Cervarix, Gardasil, GlaxoSmithKline, HPV, Merck[/tags]