Merck Sharp and Dohme cancer vaccine accepted for review
21 June 2007 00:00 in Pharmaceutical Company Product News
Merck Sharp and Dohme (MSD) has announced that the Food and Drug Administration (FDA) in the US has accepted a supplemental Biologics License Application (sBLA) for the Gardasil.
Gardasil is the world' first cervical cancer vaccine and is approved for use for a number of human papillomavirus (HPV) types in girls and women between the ages of nine and 26.
MSD is expecting a decision from the FDA by the first quarter of 2008 based on the FDA policy of responding to 90 per cent of sBLAs within ten months receipt of the application. This is part of the Prescription Drug User Fee Act.
Data on protection against vaginal and vulvar cancer caused by HPV types 16 and 18, as well as data on immune memory, is included in the sBLA, MSD has said.
Cross-protection data included in the sBLA was also filed separately on June 1st, with the FDA expected to reply within 60 days of this date as to whether it has been accepted in the same way.
The HPVs number more than 100, according to Cancer Research UK, with HPV 6 and HPV 11 a known cause of genital warts.
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