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:
You must be a registered member of MMM to post a comment.

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...