(CercleFinance.com) – Pfizer today announced that the U.S. Food and Drug Administration (FDA) has agreed to prioritize a Biological License Application (BLA) for its respiratory syncytial virus vaccine candidate ( RSV).
The FDA’s Priority Review designation reduces the standard BLA review period by four months. The Prescription Drug User Fee Act (PDUFA) deadline for an FDA decision is May 2023.
‘In the absence of RSV vaccines, older adults remain at risk of disease and potentially serious consequences, hospitalization and, in some cases, death,’ said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research & Development, Pfizer.
The regulatory submission is based on the results of the RENOIR phase 3 clinical trial.
RENOIR is a global, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, immunogenicity and safety of a single dose of VRSpreF in adults aged 60 years and older.
In August 2022, Pfizer announced positive results from an interim efficacy analysis.
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