- The European Commission has approved AstraZeneca plc AZN and Sanofi SA SNY Beyfortus (nirsevimab), long-acting antibody to prevent lower respiratory tract respiratory syncytial virus (RSV) disease in newborns and infants during their first RSV season.
- Beyfortus is the first and only single-dose passive RSV immunization program for the broad infant population, including those born healthy, term or preterm, or born with specific health conditions.
- In the pivotal MELODY efficacy study, Beyfortus met its primary endpoint of reducing the incidence of medically treated lower respiratory tract infections (LRTIs) caused by RSV by 74.5% compared to placebo through Day 151 with a single dose.
- Beyfortus also showed a comparable safety and tolerability profile
- Swedish Orphan Biovitrum AB BIOVF Synagis (palivizumab) in the MEDLEY phase 2/3 study.
- In 2019, there were approximately 33 million cases of acute lower respiratory tract infection worldwide, resulting in more than three million hospital admissions. It has been estimated that there have been 26,300 in-hospital deaths in children under the age of five.
- Price promotion: SNY shares are up 0.61% to $43.10 and AZN shares are up 0.15% to $60.02 during the premarket session last Check Friday.
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