U.S. health regulators have again withheld approval for the use of Merck & Co's Gardasil cervical cancer vaccine by women aged 27 to 45, asking for longer-term data on a test group, the drugmaker said on Friday.
The U.S. Food and Drug Administration recommended that Merck submit data when a 48-month study on the test group has been completed. It also withheld approval when Merck submitted its original request, based on data collected through an average of 24 months, last June.
Merck shares fell 2 percent in morning trading.
Gardasil, one of Merck's most successful newer products, was approved in 2006 for preventing cervical cancer and genital warts in females between the ages of 9 and 26.
The FDA letter does not affect use of the drug in that age group or Merck's application to expand use to males, the company said.
The vaccine could help prevent males from contracting human papillomavirus, which causes cervical cancer, and spreading it to females through sexual contact.
Merck on Friday also stood by its 2009 sales and earnings targets. It said it would update other elements of its forecast in a February 3 earnings conference call. In December, the company forecast Gardasil sales of $1.4 billion to $1.6 billion for 2009.
Earlier strong sales growth of the vaccine has waned, as many girls and women in the approved age group have already taken the vaccine and it is now facing competition overseas from GlaxoSmithKline's Cervarix.
Merck shares fell 60 cents to $28.76 in morning trade on the New York Stock Exchange.