Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it received input from the U.S. Food and Drug Administration (FDA) on its End-of Phase 2 questions and has reached agreement on its Phase 3 trial design for NanoFlu™, its adjuvanted recombinant quadrivalent seasonal influenza vaccine candidate for older adults aged 65 and over.
Novavax plans to initiate the pivotal Phase 3 clinical trial of NanoFlu in the fall of 2019, with top-line clinical data expected in the first quarter of 2020. The resulting data would be used to support a future biologics license application (BLA) and licensure of NanoFlu using the accelerated approval pathway. This pathway enables Novavax to conduct a non-inferiority immunogenicity clinical trial against a licensed quadrivalent comparator, with a commitment to confirm efficacy post-licensure.
“With CDC-reported overall influenza vaccine effectiveness of just 12 percent among older adults during the 2018-2019 season, the pressing need for a more effective vaccine in this population is clear,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We are committed to quickly demonstrating that our recombinant nanoparticle approach can help close the gap that exists between circulating flu strains and vaccines produced by traditional methods that frequently result in a mismatch, and ultimately, leave millions vulnerable to the serious consequences of influenza disease.”
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