FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for GARDASIL 9

Pharmaceutical Investing

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), the company’s 9-valent HPV vaccine. As quoted in the press release: The application is seeking approval …

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for GARDASIL^®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), the company’s 9-valent HPV vaccine.

As quoted in the press release:

The application is seeking approval for an expanded age indication for GARDASIL 9 for use in women and men ages 27 to 45 for the prevention of certain cancers and diseases caused by the nine human papillomavirus (HPV) types covered by the vaccine. The FDA has granted Priority Review to this sBLA and has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 6, 2018.
“Women and men ages 27 to 45 continue to be at risk for acquiring HPV, which can lead to cervical cancer and certain other HPV-related cancers and diseases,” said Dr. Alain Luxembourg, director, clinical research, Merck Research Laboratories. “We look forward to working with the FDA on the review of this application for GARDASIL 9, which, if approved, would enable more people to have access to the vaccine.”

Click here to read the full press release.

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