FDA papers bode well for AstraZeneca and Sanofi's RSV drug

7 June 2023

The US Food and Drug Administration (FDA) has published briefing papers on AstraZeneca (LSE: AZN) and Sanofi's (Euronext: SAN) Beyfortus (nirsevimab) ahead of Thursday’s meeting of the agency’s Antimicrobial Drugs Advisory Committee Meeting.

Members of the committee will discuss whether available data support a favorable benefit-risk assessment for the use of nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract (LRT) disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Papers are presented to committee members for their consideration prior to discussions, and votes that subsequently take place do not need to be adhered to when the FDA makes its final decision on whether to approve the drug.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK