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

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.