The FDA accepted AstraZeneca and Sanofi's application for their pediatric respiratory syncytial virus drug Jan. 5, and if approved, it would be the first single-dose preventive option for a virus that infects nearly all children before the age of 2.
In a news release, AstraZeneca said it expects the FDA to grant its drug nirsevimab in the third quarter of 2023, which would place it right before the 2023-24 RSV season usually hits. The drug is engineered to treat the broad infant population.
A heightened season of flu and RSV cases has strained hospitals for months, and in mid-December, physicians told Becker's a peak seems to have passed but holiday get-togethers may push numbers up again.
There are few pharmaceutical options to employ for RSV. The generic palivizumab is an approved preventive therapy for preterm babies who are 6 months and younger, and children 2 years and younger who are born with a chronic lung condition and some heart diseases, but that alone is the current treatment landscape other than supportive care.
Other drugmakers are working toward developing RSV vaccines, but none have yet been approved.