Yet another setback for Merck's blockbuster HPV vax Gardasil. The FDA will wait for more data before making a decision on whether or not to expand the indication of Gardasil for use in women ages 27 through 45, Merck announced today. The agency wants to see data from Merck's 48 month study, which the company says it expects to produce to the FDA in the fourth quarter of 2009. "Merck is committed to continuing to pursue the use of GARDASIL in this important group of women--many of whom remain at risk for HPV-related disease throughout their lifetimes," said Peter S. Kim, president, Merck Research Laboratories.
This is the second setback Merck has received for its sBLA; the company's first application, which included data from patients over an average of 24 months, was rejected in June.
Gardasil is currently approved for use in females aged 9 through 26 for the prevention of cervical, vulvar and vaginal cancers. Merck applied for an additional indication in boys and young men in December.
- read Merck's release
- check out the WSJ article for more