CORRECT: Merck: FDA Extends Review Of Gardasil's Use By Older Women

16th Jun 2010 20:25

("Merck: FDA Extends Review Of Gardasil's Use By Older Women" published at 3:06 pm EDT incorrectly stated in the seventh paragraph Merck hasn't publicly released results of a Gardasil study. Merck released the data in February. A corrected version follows.) By Peter Loftus Of DOW JONES NEWSWIRES The U.S. Food and Drug Administration has extended its review of Merck & Co.'s (MRK) application to broaden use of cervical-cancer vaccine Gardasil to include older women. Merck now expects to hear back from the FDA by the end of the year, said spokeswoman Pam Eisele. The Whitehouse Station, N.J., drug maker previously expected a response from FDA before next week's meeting of a vaccine advisory committee of the U.S. Centers for Disease Control & Prevention. "We're continuing our dialogue with the FDA to determine an appropriate way" for data from Merck's study of Gardasil in women up to age 45 to be included in the vaccine's prescribing information, Eisele said Wednesday. She declined to say why the FDA has extended its review timeline. An FDA spokeswoman said it's agency policy not to comment on ongoing reviews. The vaccine is currently approved for use in girls and women ages 9 to 26, to prevent infection by certain types of the human papillomavirus, or HPV, which can cause cervical cancer and genital warts. Last year, the FDA approved Gardasil's use in males ages 9 to 26 to prevent genital warts caused by HPV. Merck began seeking regulatory approval more than two years ago to expand Gardasil's use to include women up to age 45, based on a study showing it was effective in the older age group at preventing precancerous lesions caused by HPV types that are targeted by the vaccine, after about two years of follow-up. But the FDA delayed its approval because it wanted to see longer-term data on Gardasil's efficacy, after four years of follow-up. Merck submitted that data to FDA in late 2009, and released it publicly in February. Gardasil sales rose quickly after the product's introduction in 2006 but have slowed in recent years, as Merck has encountered difficulty persuading women ages 19 to 26 to get the shot, and now faces competition from GlaxoSmithKline PLC's (GSK) Cervarix. Merck's Gardasil sales fell 20% to $1.1 billion last year. The shot is sold in most major European markets by Merck's joint venture with Sanofi-Aventis SA (SNY). Also, the vaccine has been dogged by safety concerns, including reports of fainting and blood clots. But last year U.S. health authorities said the vaccine's benefits continue to outweigh any risks. Merck shares fell 4 cents to $35.98 Wednesday afternoon. -By Peter Loftus, Dow Jones Newswires; +1-215-656-8289; [email protected] (END) Dow Jones Newswires June 16, 2010 15:25 ET (19:25 GMT)