FDA Issues Response Letter Regarding Mercks (MRK) Use of GARDASIL in Women 27 to 45

June 25, 2008 8:59 AM EDT

Merck (NYSE: MRK) announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the supplemental biologics license application (sBLA) for the use of GARDASIL(R) in women ages 27 though 45. The agency issued the letter to advise that it has completed its review of the submission and that there are issues that preclude approval of the supplement within the expected review timeframe. Merck has already discussed with FDA their questions related to this application and expects to respond to the Agency in July. Merck submitted the sBLA for use in this expanded population in January of this year and in March the FDA designated the submission a priority review. The letter does not affect current indications for GARDASIL in females aged 9 through 26.

The FDA has also issued a complete response letter regarding the sBLA for the use of GARDASIL against non-vaccine types (cross protection). According to the FDA, the data submitted do not support extending the indication for GARDASIL to include non-vaccine HPV types.

Merck also reiterated its confidence in meeting the Company's goals of compound annual revenue growth of 4 percent to 6 percent from 2005 to 2010, including 50 percent of all joint-venture revenue and double-digit compound annual EPS growth from 2005 through 2010 excluding certain items.[SM]

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