FDA’s denies approval to Gardasil for older women

New Jersey, United States, January 10: The U.S. Food and Drug Administration has again denied approval to Merck & Co.’s drug Gardasil saying it needs more verification data to get a green signal for its use by older women.

The company was seeking FDA’s clearance for Gardasil human papillomavirus vaccine to be used by women between 27 and 45 years old.

With this decision of the U.S. health regulators, the company suffered yet another blow on its efforts to widen the use of Gardasil cervical-cancerdefine vaccine among older women. Merck shares fell by 3 percent in midday trading, as soon as the news broke.

Being one of the most successful newer products from Merck, Gardasil prevents infection with the sexually transmitted human papillomavirus (HPV), which causes cervical cancer. The drug is currently approved for use by females aged 9 to 26 years, to prevent cervical and other sexually transmitted cancers including vulvar and vaginal cancers as well as genital warts.

Earlier, the health agency had withheld approval for the drug in June last year when Merck had submitted a 24-month study data. The FDA has asked Merck to submit data after completion of 48-month study on a test group. The company hopes to provide a response in the fourth quarter of 2009.

“Even if it was approved, we're not sure what the demand was really,” said Miller Tabak analyst Les Funtleyder.

Sanford Bernstein analyst Tim Anderson stated in a research note, “Gardasil's efficacy drops sharply once females have been exposed to HPV and this is probably the genesis of the problem with the older female population that Merck has been pushing for in this new application.”

Anderson said he was uncertain about the sales’ potential and the U.S. health officials’ final decision on the drug’s use among males.

The FDA’s denial to Gardasil for older women does not interfere, in any way, with the use of drug for the approved age-group among females or the company’s application to expand the drug’s use for males between the ages 9 and 26, Merck officials maintained.

In the year 2007, Gardasil had sales of $1.5 billion. However, the sales suffered badly following the findings of a government aided Harvard study that revealed the drug was cost-effective for teenage girls but not for women in their 20s. Global sales of the vaccine fell 4 percent to $401 million in the third quarter. Despite this latest hurdle, the company forecast Gardasil sales to reach $1.4 to $1.6 billion for the current year.

Gardasil is approved in several foreign markets and sees a stiff competition from GlaxoSmithKline PLC’s Cervarix, U.K.

Merck shares went down 79 percent to $28.57 in midday trading on the NYSE (New York Stock Exchange).