- AstraZeneca Plc AZN and Sanofi SA SNY have shared detailed results from the MELODY Phase 3 trial evaluating nirsevimab in respiratory syncytial virus (RSV).
- The data showed that a single dose of nirsevimab met the primary efficacy endpoint reducing the incidence of medically attended lower respiratory tract infections caused by RSV by 74.5% compared to placebo.
- The trial also evaluated nirsevimab in infants with congenital heart disease, chronic lung disease, and prematurity.
- The data demonstrated nirsevimab had similar safety and tolerability profile compared to Swedish Orphan Biovitrum AB's Synagis (palivizumab), the only available preventative option for RSV.
- A prespecified pooled analysis of the MELODY and Phase 2b trials demonstrated a reduction of hospitalizations caused by RSV with the proposed dose of nirsevimab.
- In term and preterm infants, 21 of 786 (2.7%) infants in the placebo arm compared to nine of 1,564 (0.6%) in the nirsevimab arm experienced an RSV-associated hospitalization, giving an estimated efficacy of 77.3%.
- Although not statistically significant, there was a numerical reduction of the risk of RSV-associated hospitalizations observed in the MELODY trial alone.
- Price Action: AZN shares are down 3.09% at $60.09, SNY stock is down 1.02% at $50.54 during the market session on the last check Thursday.
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