On the heels of winning an EU nod for its RSV vaccine marketing authorization application, GSK (LSE/NYSE:GSK) has announced that FDA has accepted a Biologics License Application for its RSV vaccine candidate for older adults.
The agency also granted priority review to the vaccine, which will clip four months off the vaccine candidate’s biologics license application (BLA) review time.
The PDUFA date for the vaccine candidate is May 3, 2023.
Several other companies are also developing RSV vaccines, including Pfizer (NYSE:PFE), Icosavax (Nasdaq:ICVX) and Moderna (Nasdaq:MRNA).
GSK said that its RSV vaccine, if approved, would be the first to protect adults 60 and over from RSV infections, which can lead to pneumonia, hospitalization and death.
While researchers have sought to develop RSV vaccines since the 1960s, no vaccine against the virus is currently available.
In granting the BLA, FDA reviewed data from a prespecified interim analy…