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.
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Posted In: BiotechLarge CapNewsHealth CareGeneralBriefsEurasiaEuropean Medicines Agency
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