FDA grants fast review of Gardasil for adult women

Merck's Gardasil vaccine is seen in an undated handout photo. REUTERS/Merck & Co/Handout

NEW YORK (Reuters) - Merck & Co on Wednesday said U.S. regulators have granted a priority review for the company’s application to expand marketing of its Gardasil cervical cancer vaccine to women aged 27 through 45.

The designation means that the U.S. Food and Drug Administration is expected to make its decision on the marketing application within 6 months, rather than within the agency’s typical 10-month review period.

Gardasil, one of Merck’s fastest-growing products, is currently approved for girls and women nine through 26 years of age. It works by preventing infection with four sexually transmitted strains of the Human Papillomavirus that cause most cases of cervical cancer.

Leerink Swann analyst Seamus Fernandez called the priority review a positive surprise. In a research note, he predicted a “straightforward” regulatory review of the expanded marketing application due to the lack of serious side effects among adult women receiving Gardasil in clinical trials.

Gardasil had fourth-quarter global sales of $339 million, helping to drive Merck’s total global revenue from vaccines to $1.1 billion.

Editing by Carol Bishopric