AstraZeneca and Sanofi’s Beyfortus (nirsevimab) Receives the EC’s Approval for the Prevention of RSV Lower Respiratory Tract Disease in Infants
Shots:
- The approval was based on results from the P-III (MELODY), P-II/III (MEDLEY) & P-IIb trials evaluating Beyfortus in patients with RSV lower respiratory tract disease
- In the P-III (MELODY) & P-IIb trial, the therapy met its 1EPs i.e., reduction in the incidence of medically attended LRTI caused by RSV by 74.5% & 70.1% through 151 Days & hospitalization for RSV LRTI through 150 Days Postdose (62.1%) & (78.4%). The therapy also demonstrated a comparable safety & tolerability profile to Synagis in the P-II/III (MEDLEY) trial
- The results from the pre-specified pooled analysis of the P-IIb and (MELODY) trials, 79.5% efficacy was observed against medically attended LRTI while 77.3% against RSV LRTI hospitalizations
Ref: AstraZeneca | 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.
