Issue link: https://beckershealthcare.uberflip.com/i/1516189
SANOFI, 1 Discovery Drive, Swiftwater, PA 18370 Beyfortus ™ is the fi rst and only long-acting antibody indicated for the prevention of RSV lower respiratory tract disease in term and preterm infants 1 Proven strong and consistent effi cacy against MA RSV-LRTI 1 * Demonstrated safety profi le versus placebo (Trials 04 and 03) and versus palivizumab (Trial 05) 1† • The most common adverse reactions in Trial 04 and Trial 03 were rash (0.9%) and injection site reactions (0.3%) • Adverse reactions reported among Trial 05 subjects were similar to Trials 04 and 03 RSV disease protection that extends through 5 months based on clinical data 1 Healthy term and preterm infants ≥35 wGA (Trial 04) 74.9% RRR (95% CI: 50.6, 87.3; P<0.001) Beyfortus: 1.2% (12/994) Placebo: 5.0% (25/496) Healthy preterm infants ≥29 to <35 wGA (Trial 03) 70.1% RRR (95% CI: 52.3, 81.2; P<0.001) Beyfortus: 2.6% (25/969) Placebo: 9.5% (46/484) Primary endpoint: Incidence of MA RSV-LRTI vs placebo through 150 days post one dose ©2023 Sanofi Pasteur Inc. All rights reserved. MAT-US-2308449-v1.0-10/2023 CI, confi dence interval; IM, intramuscular; MA RSV-LRTI, medically attended respiratory syncytial virus lower respiratory tract infection; RRR, relative risk reduction; wGA, weeks gestational age. *Results of Trials 04 and 03 for infants entering their fi rst RSV season. Trial 04 evaluated the effi cacy of a single dose of Beyfortus (50 mg IM if <5 kg weight, 100 mg IM if ≥5 kg weight) vs placebo in 1,490 healthy term and preterm infants (≥35 wGA). Trial 03 evaluated the effi cacy of a single 50 mg dose of Beyfortus vs placebo in 1,453 healthy preterm infants (≥29 to <35 wGA). † The Safety Population includes all infants who received the recommended dose of Beyfortus in Trials 04 and 03: Primary and Safety cohorts from Trial 04; infants who weighed <5 kg and who received the recommended dose of Beyfortus (single 50 mg IM dose) in Trial 03. Trial 05 was a Phase 2/3 study that evaluated the safety of a single dose of Beyfortus (50 mg or 100 mg) in infants with chronic lung disease (CLD) or congenital heart disease (CHD) and preterm infants (<35 wGA) entering their fi rst RSV season. Reference: 1. Beyfortus (nirsevimab-alip). Prescribing Information. Sanofi . IMPORTANT SAFETY INFORMATION (cont'd) • Use in Individuals with Clinically Signifi cant Bleeding Disorders: As with other IM injections, Beyfortus should be given with caution to infants and children with thrombocytopenia, any coagulation disorder or to individuals on anticoagulation therapy. Most common adverse reactions with Beyfortus were rash (0.9%) and injection site reactions (0.3%). Please see Brief Summary of full Prescribing Information on the following pages.