Beyfortus^® (nirsevimab-alip) 50 mg and 100 mg Injection Efficacy & Safety Profile Overview

Studied across a broad range of infant populations entering their first RSV season¹

Studied across a broad range of infant populations entering their first RSV season overview graph

Trial 04 continued monitoring for the primary cohort and an additional 1,522 subjects to include all subjects.⁴

*For neonates and infants in their first season, the recommended dose is 50 mg for infants <5 kg or 100 mg for infants ≥5 kg via IM administration. For children up to 24 months of age who remain at increased risk for severe RSV disease in their second season, the recommended dose is a single 200 mg dose administered as 2 IM injections (2 x 100 mg).¹
†Included 128 preterm infants born at <29 wGA.¹
‡Incidence of RSV-LRTI (inpatient or outpatient) due to confirmed RSV through 150 days (descriptive).³

Proven strong and consistent efficacy against RSV disease¹

Trial 04 (Primary Cohort): healthy term and late preterm infants (≥35 wGA)^1*†‡

Primary endpoint: incidence of MA RSV-LRTI vs placebo through 150 days post 1 dose

Medically attended (MA) includes all healthcare provider visits such as physician’s office, urgent care, emergency room, and hospitalizations

74.9% RRR incidence of MA RSV-LRTI (inpatient or outpatient)

Signs of LRTI involvement included rhonchi, rales, crackles, or wheezing and at least one sign of worsening clinical severity including at least one of the following: increased respiratory rate, hypoxemia, acute hypoxic or ventilatory failure, new onset apnea, nasal flaring, retractions, grunting, or dehydration due to respiratory distress.

CI, confidence interval; RRR, relative risk reduction;

^*1,490 healthy term and late preterm infants (≥35 wGA) in Trial 04.
^†The primary efficacy analysis for Trial 04 is based on infants from the Primary Cohort.
^‡Efficacy for MA RSV-LRTI based on relative risk reduction against placebo adjusted for age at randomization.

Study design

Time-to-Event Analysis

Randomization and Dosing

RSV-LRTI Hospitalization

Proven strong and consistent efficacy against RSV disease¹

Trial 03: healthy preterm infants (≥29 to <35 wGA)^1*†

70.1% RRR incidence of MA RSV-LRTI (inpatient or outpatient)

^*1,453 healthy preterm infants (≥29 to <35 wGA) in Trial 03.
^††Efficacy for MA RSV-LRTI based on relative risk reduction against placebo adjusted for age at randomization and hemisphere.

Study Design

Time-to-Event Analysis

Randomization and Dosing

Beyfortus demonstrated consistent safety profile across multiple infant cohorts¹˒²˒⁵˒⁹

Trial 04 and Trial 03 were pooled to evaluate the safety of Beyfortus (N=2,570) compared to placebo (N=1,284)

The Beyfortus group included 1,998 healthy term and late preterm infants (≥35 wGA) and 572 preterm infants (≥29 to <35 wGA)
Adverse reactions were reported in 1.2% of infants who received Beyfortus; most (97%) of adverse reactions were mild to moderate in severity

Most Common Adverse Reactions Reported at an Incidence Higher Than Placebo in the Safety Population (Trial 04 and Trial 03)^1*

Adverse reaction	Beyfortus N=2,570	Placebo N=1,284
Rash† (occurring within 14 days post dose)	0.9%	0.6%
Injection Site Reaction^‡ (occurring within 7 days post dose)	0.3%	0.0%

^*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.
^†Rash was defined by the following grouped preferred terms: rash, rash macular, rash maculopapular, rash papular.
^‡Injection site reaction was defined by the following grouped preferred terms: injection site reaction, injection site pain, injection site induration, injection site edema, injection site swelling.

Safety studied in infants and children at higher risk for severe RSV disease¹

The safety of Beyfortus was evaluated in Trial 05, a Phase 2/3, randomized, double-blind, palivizumab-controlled multicenter trial in infants and children at high risk for severe RSV disease.

First RSV season¹: infants born at <35 wGA and infants with CLD of prematurity and hemodynamically significant CHD

Adverse reactions reported among Trial 05 infants who received Beyfortus in their first RSV season were similar to those reported in infants who received Beyfortus in Trials 03 and 04

Second RSV season¹: children up to 24 months with CLD of prematurity and hemodynamically significant CHD

The safety profile of Beyfortus in these children during their second RSV season was consistent with the safety profile of Beyfortus observed during their first RSV season

Study Design

Trial 05: analysis of Beyfortus vs palivizumab in infants at higher risk of severe RSV disease¹˒²

First season study design: randomized, double-blind, palivizumab-controlled multicenter safety study¹˒²

Second season study design: randomized, double-blind, palivizumab-controlled multicenter safety study¹˒²

Forty children who received palivizumab in the first RSV season received Beyfortus in their second RSV season; and 42 children received palivizumab in both first and second RSV seasons.

Baseline characteristics: at randomization, in the preterm cohort, 77 infants (13%) were <29 wGA; and 499 (81%) were ≥29 to <35 wGA. In the CLD/CHD cohort, 70% had CLD; 34% had hemodynamically significant CHD; 123 infants (40%) were <29 wGA, 28% were ≥29 to <35 wGA; and 32% were ≥35 wGA.

PK, pharmacokinetic.

^*Signs of LRTI involvement included rhonchi, rales, crackles, or wheezing and at least one sign of worsening clinical severity, including at least one of the following: increased respiratory rate, hypoxemia, acute hypoxic or ventilatory failure, new onset apnea, nasal flaring, retractions, grunting, or dehydration due to respiratory distress.

Exploratory efficacy: in preterm infants (<35 wGA) or those with CLD/CHD there was a numerically lower incidence of MA RSV-LRTI with Beyfortus compared with palivizumab^1,3†

Trial 05 was not powered for efficacy but efficacy was assessed as a secondary endpoint
The clinical significance of these data is not known

There were no cases of MA RSV-LRTI through 150 days in the second RSV season

^†Trial 05 was a Phase 2/3, randomized, double-blind, palivizumab-controlled study evaluating the safety of Beyfortus in infants with CLD or CHD and preterm infants (<35 wGA) entering their first RSV season. Children up to 24 months with CLD or CHD could continue in Trial 05 and receive Beyfortus or palivizumab prior to their second RSV season. The efficacy was established based on extrapolation of the efficacy from Trial 04 and Trial 03 to the population enrolled in Trial 05 based on similar Beyfortus exposures among infants enrolled in Trials 04 and 05.

Pre-filled Syringe for Convenient Administration¹

Product images are representative of scale - actual size of packaging may be different.

Cost and Coverage With Beyfortus

Want to Know More About Beyfortus?

Explore the FAQs

References: 1. Beyfortus (nirsevimab-alip). Prescribing Information. Sanofi. 2. Domachowske J, Madhi SA, Simões EAF, et al. Safety of nirsevimab for RSV in infants with heart or lung disease or prematurity. N Engl J Med. 2022;386(9)(suppl):1-42. 3. Domachowske J, Madhi SA, Simões EAF, et al. Safety of nirsevimab for RSV in infants with heart or lung disease or prematurity. N Engl J Med. 2022;386(9):892-894. 4. Muller WJ, Madhi SA, Nuñez BS, et al. Nirsevimab for prevention of RSV in term and late-preterm infants. N Engl J Med. 2023;388(16)(suppl):1533-1534. 5. Hammitt LL, Dagan R, Yuan Y, et al. Nirsevimab for prevention of RSV in healthy late-term and term infants. N Engl J Med. 2022;386(9):837-846. 6. Hammitt LL, Dagan R, Yuan Y, et al. Nirsevimab for prevention of RSV in healthy late-preterm and term infants. N Engl J Med. 2022;386(suppl):837-846. 7. Muller WJ, Madhi SA, Nuñez BS, et al. Nirsevimab for prevention of RSV in term and late-preterm infants. N Engl J Med. 2023;388(16):1533-1534. 8. Data on file, November 2023. 9. Griffin MP, Yuan Y, Takas T, et al. Single-dose nirsevimab for prevention of RSV in preterm infants. N Engl J Med. 2020;383(5):415-425. 10. Griffin MP, Yuan Y, Takas T, et al. Single-dose nirsevimab for prevention of RSV in preterm infants. N Engl J Med. 2020;383(5)(suppl):415-425.

Beyfortus^® (nirsevimab-alip) 50 mg and 100 mg Injection Efficacy & Safety Profile Overview

Studied across a broad range of infant populations entering their first RSV season¹

Trial 04 continued monitoring for the primary cohort and an additional 1,522 subjects to include all subjects.⁴

Proven strong and consistent efficacy against RSV disease¹

Trial 04 (Primary Cohort): healthy term and late preterm infants (≥35 wGA)^1*†‡

Randomized, double-blind, placebo-controlled multicenter Trial 04¹˒⁵

Lower respiratory tract infections (LRTIs) associated with respiratory syncytial virus (RSV)⁵

Study design with efficacy monitoring for 151 days and safety monitoring for 361+ days⁶

Proven strong and consistent efficacy against RSV disease¹

Trial 03: healthy preterm infants (≥29 to <35 wGA)^1*†

Randomized, double-blind, placebo-controlled multicenter Trial 03¹˒⁹

Time to first medically attended RSV lower respiratory tract infection⁹

Study design with efficacy monitoring for 151 days and safety monitoring for 361 days¹⁰

Beyfortus demonstrated consistent safety profile across multiple infant cohorts¹˒²˒⁵˒⁹

Safety studied in infants and children at higher risk for severe RSV disease¹

Exploratory efficacy: in preterm infants (<35 wGA) or those with CLD/CHD there was a numerically lower incidence of MA RSV-LRTI with Beyfortus compared with palivizumab^1,3†

There were no cases of MA RSV-LRTI through 150 days in the second RSV season

Pre-filled Syringe for Convenient Administration¹

Cost and Coverage With Beyfortus

Want to Know More About Beyfortus?

Important safety information

Contraindication

Indication

Important safety information

Contraindication

Warnings and Precautions

Beyfortus® (nirsevimab-alip) 50 mg and 100 mg Injection Efficacy & Safety Profile Overview

Studied across a broad range of infant populations entering their first RSV season¹

Trial 04 continued monitoring for the primary cohort and an additional 1,522 subjects to include all subjects.⁴

Proven strong and consistent efficacy against RSV disease¹

Trial 04 (Primary Cohort): healthy term and late preterm infants (≥35 wGA)1*†‡

Proven strong and consistent efficacy against RSV disease¹

Trial 03: healthy preterm infants (≥29 to <35 wGA)1*†

Beyfortus demonstrated consistent safety profile across multiple infant cohorts¹˒²˒⁵˒⁹

Safety studied in infants and children at higher risk for severe RSV disease¹

Pre-filled Syringe for Convenient Administration¹

Cost and Coverage With Beyfortus

Want to Know More About Beyfortus?

Important safety information

Contraindication

Indication

Important safety information

Contraindication

Warnings and Precautions

Beyfortus^® (nirsevimab-alip) 50 mg and 100 mg Injection Efficacy & Safety Profile Overview

Trial 04 (Primary Cohort): healthy term and late preterm infants (≥35 wGA)^1*†‡

Trial 03: healthy preterm infants (≥29 to <35 wGA)^1*†