GSK announced that the U.S. FDA has granted it Priority Review for its respiratory syncytial virus (RSV) vaccine candidate in older adults — giving the drugmaker a leg up in a what has become a heated race to approval.
The Priority Review designation reduces the regulatory review period for GSK's BLA by four months — giving the vaccine a PDUFA date of May 3, 2023.
The BLA is based on positive data from an interim analysis of the pivotal AReSVi-006 phase 3 trial, which showed high overall vaccine efficacy against RSV lower respiratory tract disease (LRTD) in adults aged 60 years and older.
This is the third major regulatory milestone for GSK’s RSV older adult vaccine candidate in a closely watched race for approval across the industry. GSK's vaccine also has regulatory submission acceptances by the European Medicines Agency and Japan’s Ministry of Health, Labour and Welfare.
Yesterday, Pfizer shared positive data for its maternal RSV vax and plans to seek approval by the end of the year. Back in August, Pfizer announced positive top-line results of an interim analysis for another phase 3 clinical trial testing the same vaccine — RSVpreF — in adults ages 60 years or older. Sanofi and AstraZeneca's jointly developed vaccine, nirsevimab, which is designed to protect infants from RSV, is already in the hands of regulators.
