FDA advisors endorse new RSV antibody drug for babies – Gist It

FDA advisors endorse new RSV antibody drug for babies

FDA advisors recommend approval for a new RSV antibody drug to protect infants from serious lung illnesses.

Driving the news: On Thursday, the panel voted in favor of FDA approval for the injectable antibody medication called nirsevimab after testimony from drugmaker AstraZeneca, FDA scientists, and the public.
* The drug would offer babies protection during their first RSV seasons with a single shot.

The bigger picture: RSV is a viral infection that causes hospitalization for 58,000 to 80,000 young children each year, making it the leading cause of infant hospitalization in the U.S.

What’s next: The FDA is expected to make a decision in the third quarter of 2023, and if approved, the companies plan to launch the preventive shot in the U.S. ahead of the 2023-2024 RSV season.
* The antibody has already been approved in the EU and is under consideration in several Asian countries.

View original article on NPR

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June 8, 2023

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