Europe Approves AstraZeneca-Sanofi Partnered Antibody To Prevent RSV Infection In Infants

The European Commission has approved AstraZeneca plc AZN and Sanofi SA’s SNY Beyfortus (nirsevimab) long-acting antibody to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.
Beyfortus is the first and only single-dose RSV passive immunization for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.
In the pivotal MELODY efficacy trial, Beyfortus met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV by 74.5% vs. placebo through day 151 with a single dose.
Beyfortus also demonstrated a comparable safety and tolerability profile to
Swedish Orphan Biovitrum AB's BIOVF Synagis (palivizumab) in the MEDLEY Phase 2/3 trial.
Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalizations. It was estimated that there were 26,300 in-hospital deaths of children younger than five years.
Price Action: SNY shares are up 0.61% at $43.10, and AZN shares are up 0.15% at $60.02 during the premarket session on the last check Friday.