The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults.
Termination of the branaplam program, according to Novartis, was due to an “overall assessment of the risk-benefit profile” observed in a mid-stage clinical trial that raised safety concerns last year.
Wilson Bryan, a key decision maker in the agency’s oversight of genetic medicines, will leave next month amid an organizational revamp of his office, the FDA confirmed.
The company expects yearly revenue from Comirnaty and Paxlovid to fall by nearly two thirds in 2023 amid lower vaccination rates and a shift to private market sales.
