FDA puts off decision on Merck’s Gardasil–again

Fierce Pharma

June 17, 2010 — 9:40am ET | By Tracy Staton

Merck must feel like it’s waiting for Godot. The drugmaker got another wait-and-see notice from FDA in its bid to broaden use of Gardasil, the human papillomavirus vaccine, to women ages 27 to 45. Merck had expected to get word from the agency next week. Now, it says FDA will decide by year’s end.

“We’re continuing our dialogue with the FDA,” Merck spokeswoman Pam Eisele told Dow Jones. And it’s been a long dialogue. The company originally asked to market Gardasil to older women two years ago. As you know, the vaccine is currently approved to prevent HPV infection in girls and young women ages 9 to 26. In boys and young men of the same age, it’s approved as a genital warts preventive.

Back then, Merck submitted two-year data on the vaccine’s ability to prevent precancerous lesions caused by certain strains of HPV. The FDA wanted longer-term data. Merck turned in that data to FDA late last year and released it to the public in February, Dow Jones notes. The efficacy rate after four years of follow up was 88.7 percent compared with 91 percent after two years.

Gardasil was expected to be a huge hit for Merck, and though sales started out strong, they’ve tapered off. Recently, a study found that only 30 percent of eligible girls and young women had received the vaccine, despite intensive marketing campaigns. Broadening use of the shot–to males and older women–is part of the company’s strategy for turning the sales trend upward.

– read the Dow Jones story
– get more from Reuters

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.