Posted by: admin in ‘Pharmacy Drugs’
16 October 2010
WASHINGTON – An FDA advisory panel today voted to recommend approval of GlaxoSmithKline‘s Cervarix vaccine for use against the two strains of human papillomavirus (HPV) that cause 70% of cervical cancers.
In a separate action, the Vaccines and Related Biologics Committee recommended that the agency okay Merck’s application to extend the use of its HPV vaccine, Gardasil, against genital warts in males ages 9 through 26.
The panel’s near unanimous vote Wednesday on the use of Cervarix against HPV types 16 and 18 in females ages 15 to 26 makes it likely that the FDA will ultimately approve the first competitor to Gardasil, which has been used for three years in girls and women from 9 to 26 years of age to ward off four strains of HPV.
The FDA is not bound by the recommendations of its panel of outside experts, but usually follows the committee’s advice.
The panel voted 12-1 that the manufacturer had demonstrated the effectiveness of Cervarix and 11-1 that it had demonstrated safety.
However, members of the panel pressed for strong aftermarket follow-up after discussing data that showed a somewhat higher rate of miscarriages around the time of vaccination and a small number of neurological problems.
Cervarix has already been approved in 98 countries.
Read the entire article here.