Merck Gets FDA’s Priority Review For Its Cervical Cancer Shot, Gardasil
Submitted by Carina Rose on Thu, 03/20/2008 - 08:00
Whitehouse Station, New Jersey: The US pharmaceutical giant, Merck & Co on Wednesday announced that the FDA has granted a priority review for its “gardasil,” the vaccine that combats the virus linked to cervical cancer in women aging from 27 through 45 years.
It signifies that the US FDA is expected to pronounce its verdict on the marketing application within 6 months, rather than within the agency's typical 10-month review period.
One of the fast growing in popularity Merck's products, Gardasil is currently available on the market for girls and women of 9 through 26 years of age. If the FDA approves it further, the shot would be available for use by women up to age 45.
The jab promising in the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused human papilloma virus – Gardasil works by preventing infection with four sexually transmitted strains of the Human Papillomavirus that cause most cases of cervical cancer. Gardasi is given by injection in three stages over a six-month period.
According to Merck, about 6.2 million men and women get infected with HPV every year in the United States. Approximately 20 million US people are currently infected with HPV. In some cases, the virus goes away on its own, but if unrecognized and untreated, it can lead to cervical cancer, that is the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 280,000 deaths each year. There were an estimated 11,000 new cases of cervical cancer and 3,600 deaths in the United States in 2007.
Calling the priority review a positive surprise, Leerink Swann analyst Seamus Fernandez, in a research note, 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. The pharma was trading on the New York Stock Exchange at $43.75, up 56 cents.
