Novavax gets fast track designation for NanoFlu in older adults


The FDA granted fast track designation for Novavax’s (NASDAQ:NVAX) NanoFlu, a seasonal influenza vaccine candidate, in adults 65 years of age and older.

“We believe that NanoFlu will offer an innovative improvement, compared with traditional egg-based vaccines, which frequently result in mismatch and poor effectiveness,” Stanley Erck, president and CEO of Novavax, said in a statement.

NanoFlu’s ongoing Phase 3 clinical trial is intended to evaluate its immunogenicity and safety, compared with the quadrivalent formulation of Fluzone. Top-line clinical data from the trial is expected by the end of the first quarter of 2020 and could support a U.S. biologics license application and future licensure using the FDA’s accelerated approval pathway.

Sign up for the BioTuesdays weekly newsletter

Get the latest news on the healthcare industry’s corporate and clinical developments, executive moves, and market updates. Every Tuesday, in your inbox.