Novavax Confirms Accelerated Approval Pathway Available for Licensure of NanoFlu™
- Pivotal Phase 3 clinical trial expected to initiate in the fall of 2019
- Top-line clinical data expected in the first quarter of 2020
“NanoFlu’s encouraging results observed in prior clinical trials, which demonstrated improved immune responses against licensed comparators, provide us confidence in the future success of the Phase 3 clinical trial,” said
“The accelerated approval pathway, combined with the strategic partnership we announced today with Catalent Biologics, allow us to efficiently and cost effectively complete the clinical development of NanoFlu through BLA and licensure,” said
Previously Reported Phase 2 Clinical Trial Results with NanoFlu
Earlier this year,
Influenza is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death. Serious illness occurs not only in susceptible populations such as infants, young children and older adults, but also in the general population largely because of infection by continuously evolving strains of influenza which can evade the existing protective antibodies in humans. An estimated one million deaths globally each year are attributed to influenza. Current estimates for seasonal influenza vaccine growth in the top seven markets (U.S.,
About NanoFlu™ and Matrix-M™
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by
About Accelerated Approval
Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments. Such an approval will be based on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. For seasonal influenza vaccines, the hemagglutination inhibition (HAI) antibody response may be an acceptable surrogate marker of activity that is reasonably likely to predict clinical benefit. To be considered for accelerated approval, a biologics license application for a new seasonal influenza vaccine should include results from one or more well-controlled studies designed to meet immunogenicity endpoints and a commitment to conduct confirmatory post-marketing studies of clinical effectiveness in preventing influenza.
Statements herein relating to the future of
Senior Manager, Investor & Public Relations
Brandzone/Speak Life Science
Source: Novavax, Inc.