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Novavax influenza vaccine gets US FDA fast-track status

Novavax Inc. said the U.S. Food and Drug Administration granted a fast-track designation to its experimental vaccine NanoFlu in combination with Matrix-M for seasonal viral respiratory infections in senior adults.

Matrix-M, an immune response enhancer also developed by Novavax, is an adjuvant that enables a vaccine to induce a stronger immune response.

The tag will cover the development of the NanoFlu to protect people 65 years and older against influenza, which can have serious complications among older patients.

NanoFlu is a quadrivalent influenza vaccine that is designed to safeguard against two influenza A viruses and two influenza B viruses.

Gaithersburg, Md.-based company is conducting a phase 3 trial to compare the immune response and safety for the vaccine against Sanofi's Fluzone.

Sanofi's influenza vaccines portfolio including Fluzone generated €735 million during the third quarter of 2019, according to the Paris-based pharmaceutical giant's earnings release.

Influenza vaccine business in the top seven markets is expected to grow up to $5.3 billion by 2025, Novavax noted in its Jan. 15 press release.

The FDA's fast-track status facilitates the development and expedites the review of new drugs and vaccines that show the potential to satisfy an unmet medical need. Additionally, the status makes the company eligible for more frequent meetings and communication with the regulator.

Under the designation, Novavax will also have the option to submit a rolling application for NanoFlu, and the company may be eligible for a shorter six-month priority review instead of standard submission that takes 10 months.