Novavax ($NVAX) is racing to get its vaccine against respiratory syncytial virus on the market and it just got a boost: The FDA fast-tracked its candidate for the protection of older adults.
The FDA previously granted the candidate, dubbed RSV F, fast-track designation in December 2014, for use in the maternal immunization of infants. "Fast Track designation could allow for an expedited timeline to licensure, accelerating the access to this vaccine for the most vulnerable populations,” CEO Stan Erck said in a statement. Back in October, Novavax scored an $89 million Gates Foundation grant to fund the vaccine’s development.
The Washington Business Journal reports that the company plans to file for regulatory approval in 2017 and enter the market in time for the 2018 RSV season.
The FDA’s action emphasizes a “significant unmet medical need” for an RSV vaccine in the elderly population, Erck said in the statement. The candidate is currently in Phase I trials as a pediatric vaccine and in Phase III trials in older adults and pregnant women. Novavax expects to announce Phase III results for older adults in the third quarter of this year, R&D chief Dr. Greg Glenn said in the statement.
While the development and licensure of an RSV vaccine has been a priority for decades, there is still no FDA-approved vaccine for the virus. Novavax’s closest competitor is AstraZeneca’s MedImmune, whose candidate, MEDI8897, was fast-tracked in April 2015. It is currently in Phase II. Bavarian Nordic's candidate is in Phase I and the Danish company reported last week positive topline results from that trial.
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