FDA advisors recommend RSV antibody drug for infants.
TL;DR Summary
A panel of FDA advisers has recommended the approval of a new antibody drug called nirsevimab to protect infants from serious lung illnesses caused by respiratory syncytial virus (RSV). The drug would offer babies protection from the virus in their first RSV seasons with a single shot and would be more affordable and widely available than the existing preventive drug. RSV is a viral infection that puts tens of thousands of young children in the hospital each year, making it the leading cause of hospitalization among infants in the U.S. The FDA is expected to decide on the drug's approval in the third quarter of 2023.
- RSV antibody drug gets backing from FDA advisors, paving the way for approval : Shots - Health News NPR
- FDA panel recommends drug to prevent RSV in infants NBC News
- F.D.A. Panel Recommends R.S.V. Shot to Protect Infants The New York Times
- Sanofi, AstraZeneca's RSV antibody for infants easily clears FDA adcomm, likely setting up approval FiercePharma
- FDA Panel Endorses mAb to Prevent RSV in Infants Medpage Today
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