Novavax (NASDAQ:NVAX) reported that the FDA recently made the accelerated approval pathway available for NanoFlu, and that Novavax will be pursuing that pathway for licensure of the vaccine.
In a Phase 2 clinical trial, NanoFlu, a nanoparticle vaccine for seasonal influenza, demonstrated improved immune responses compared with the best-selling flu vaccine in the older adult market.
“The accelerated approval pathway allows us to potentially obtain U.S. licensure more expeditiously, and ideally, deliver a greatly needed improved flu vaccine, which could reduce the tremendous medical and economic burden of influenza,” Dr. Gregory Glenn, Novavax’s president of research and development, said in a statement.
Novavax plans to conduct an end-of-Phase 2 meeting with the FDA in the third quarter of 2019 to discuss the Phase 3 clinical trial design. The company intends to initiate a Phase 3 trial in the fall of 2019, with topline clinical data expected in the first quarter of 2020.
