Gardasil sBLA given priority review

Share this article:

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.


Share this article:

Email Newsletters

More in News

Five things for Pharma Marketers to know: Wednesday, August 27

Five things for Pharma Marketers to know: Wednesday, ...

Allergan sets a shareholder voting date, Novo describes the types of acquisitions it will consider, and the AstraZeneca-Pfizer talks can now reopen.

Eli Lilly and BI's Jardiance hits shelves

Eli Lilly and BI's Jardiance hits shelves

The new SGLT-2 inhibitor is on shelves less than a month after FDA approval.

PhRMA Urges Court to Reject Off-Label Promotion Case

PhRMA Urges Court to Reject Off-Label Promotion Case

The Pharmaceutical Research and Manufacturers of America (PhRMA) says a California federal court should dismiss a whistleblower's False Claims Act suit against three drug companies on First Amendment grounds