Merck said today that the FDA has granted priority review status to the company's supplemental Biologics License Application (sBLA) for Gardasil (human papillomavirus quadrivalent) for use in women aged 27 through 45.
Priority designation is intended for products or indications that address unmet medical needs. Under the Prescription Drug User Fee Act (PDUFA), the FDA is required to review and act on 90% of priority review BLAs within six months of receipt.
Gardasil is currently indicated for girls and women nine through 26 years of age for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16 and 18.
Analysts estimate that Gardasil may generate up to $3 billion in peak annual sales for Merck. Gardasil sales totaled $1.1 billion during the first nine months of 2007, according to Merck figures.
Meanwhile, GlaxoSmithKline's HPV vaccine Cervarix still awaits FDA approval. Regulators requested more information on the treatment in a letter to the drug's maker last December.
The anticipated marketing clash between the two products is expected to be one of the most competitive the industry has seen.
Although Gardasil has an early lead in the key US market, positive results from an ongoing head-to-head trial against Gardasil could facilitate Cervarix's uptake.
Gardasil targets four subtypes of HPV- compared to Cervarix's two, thus protecting from most cases of cervical cancer as well as genital warts, leading many analysts to believe that the Merck vaccine, with its first-to-market advantage, will win the majority of sales.