Posted by Michael Wonder on 14 Jun 2018
FDA grants priority review to Merck’s supplemental biologics license application for Gardasil 9 in women and men ages 27 to 45 for the prevention of certain HPV-related cancers and diseases
13 June 2018 - Merck today announced that the U.S. FDA has accepted for review a new supplemental biologics license application for Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant), the company’s 9-valent HPV vaccine.
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 types covered by the vaccine.
The FDA has granted priority review to this application and has set a Prescription Drug User Fee Act, or target action, date of 9 October 2018.
