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Merck Gardasil sBLA Gets Priority Review In Older Women

This article was originally published in The Pink Sheet Daily

Executive Summary

Company seeks approval of the vaccine for women ages 27 through 45.

FDA granted Merck priority review of an sBLA to extend use of the Gardasil vaccine to women ages 27 through 45, Merck announced March 19. The indication is one of several label expansions Merck is seeking for the human papilloma virus vaccine this year.

The vaccine has been approved since 2006 for women and girls ages nine to 26 to prevent cervical cancer, cervical pre-cancers, vulvar pre-cancers and vaginal pre-cancers caused by HPV types 16 and 18, as well as genital warts and low-grade cervical lesions caused by HPV types 6, 11, 16 and 18 (1 (Also see "Merck’s Gardasil HPV Vaccine Clears FDA" - Pink Sheet, 8 Jun, 2006.)).

Adoption of the vaccine has been more brisk in younger patients, however, particularly girls ages nine to 18, according to Merck.

The company had indicated in December that it would file two sBLAs for Gardasil by the end of the year. In addition to the filing for use in older women, Merck said it would seek an additional indication to treat men ages 16 to 26 (2 (Also see "Merck To File Two More Gardasil sBLAs In Late 2007/Early 2008" - Pink Sheet, 4 Dec, 2007.)).

The company also submitted data to FDA last year for cross protection and protection against vaginal and vulvar cancers.

As Merck seeks to expand labeling for the vaccine, the company is putting even more distance between Gardasil and GlaxoSmithKline's investigational HPV vaccine Cervarix .

GSK received a "complete response" letter from FDA for its BLA for Cervarix in December. The company has said it expects to respond to the letter in the second quarter, but that the product likely could require an advisory committee review prior to approval (3 (Also see "GSK Will Answer FDA “Complete Response” Letter For Cervarix In Second Quarter" - Pink Sheet, 7 Feb, 2008.)).

-Jessica Merrill ([email protected])

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