Therapy Areas: Vaccines
FDA Priority Review Granted to Merck sBLA for Gardasil9 to Expand Age Indication
18 June 2018 - - Kenilworth, New Jersey-based global healthcare solutions provider Merck (NYSE: MRK), known as MSD outside of the US and Canada, has been informed that the US Food and Drug Administration (FDA) has accepted for priority review a new supplemental biologics license application (sBLA) for Gardasil9, the company's 9-valent human papilloma virus (HPV) vaccine, the company said.
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 HPV types covered by the vaccine.
Five of the HPV types in Gardasil 9 are the most common cervical cancer-causing types worldwide. Seven HPV types in the vaccine cause 90% of cervical cancer cases, 80% of high-grade cervical lesions, and 50% of low-grade cervical lesions.
In addition, these seven HPV types cause 90% of HPV-related vulvar cancers, 85% of HPV-related vaginal cancers, and 90% of HPV-related anal cancers. Two of the other HPV types in the vaccine cause approximately 90% of genital warts cases.
Merck provides healthcare solutions worldwide through four segments: pharmaceutical, animal health, healthcare services, and alliances.
The company serves drug wholesalers and retailers, hospitals, government agencies and entities, physicians, physician distributors, veterinarians, distributors, animal producers, and managed health care providers.
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