Bavarian Drops RSV Program After Phase III Flop
Shifts Focus To Chikungunya
The Danish firm’s respiratory syncytial vaccine disappointed in a Phase III trial, marking an unexpected setback after a year of mpox-related successes, prompting all eyes to turn towards a recently-acquired chikungunya vaccine program.
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Safety signals were the most common cause of discontinued candidates in the breakthrough therapy designation program in 2023.
Bavarian Nordic is planning regulatory submissions on both sides of the Atlantic next year for its vaccine against chikungunya virus, CHIKV VLP, after it demonstrated protection from the mosquito-borne disease in a second Phase III study.
Arexvy will launch in the US in time for the fall 2023 RSV season for adults 60 and older, GSK said. Pfizer’s Abrysvo is also pending at the FDA.