AstraZeneca and Sanofi’s Beyfortus (nirsevimab) Receive EMA's CHMP Positive Opinion for the Prevention of RSV Lower Respiratory Tract Disease
Shots:
- The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Beyfortus to prevent RSV lower respiratory tract disease in newborns & infants
- The opinion was based on the P-III (MELODY), P-II/III (MEDLEY), and P-IIb trials evaluating Beyfortus. In the (MELODY) & P-IIb trials, the therapy met its 1EPs of reducing the incidence of medically attended LRTI caused by RSV during the RSV season with a single dose, no clinical differences in safety results were observed & showed comparable safety & tolerability profile to palivizumab in the P-II/III (MEDLEY) trial
- If Beyfortus is approved, it will be 1st single-dose passive immunization for the infant incl. born healthy, at term or preterm, or with specific health conditions
Ref: Globenewswire| Image: AstraZeneca
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
