Further FDA delays for Gardasil sBLA

The USA's Merck & Co has received a second "complete response" letter from the Food and Drug Administration, further delaying the supplemental  Biologics License Application to extend the use of its human  papillomavirus vaccine Gardasil, currently indicated for women aged nine  through 26, to those up to 45 years old. The firm's shares fell 0.6% to  $29.19 on the day of the news.

The agency has completed its review of the response that Merck provided  in July 2008 and has asked for final data from the ongoing 48-month  study of the vaccine in this indication. The initial sBLA included data  collected during the first 24 months of the trial, which is when all  pre-specified endpoints had been met. Following a review of the final  results of the study, Merck anticipates providing a response to the  agency in the fourth quarter.

Nonetheless, the firm reconfirmed its 2009 sales guidance as between  $23.7 billion and $24.2 billion and its earnings per share range of  $2.95 to $3.17.