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.


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.

Proven strong and consistent efficacy against RSV disease¹

Trial 03: healthy preterm infants (≥29 to <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
70.1% 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.

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 reactionBeyfortus
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%

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
Order Beyfortus Packaging Image

Pre-filled Syringe for Convenient Administration¹

antibody

Cost and Coverage With Beyfortus

Beyfortus mAb image

Want to Know More About Beyfortus?

Indication

Beyfortus is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in:

  • Neonates and infants born during or entering their first RSV season.
  • Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Important safety information

Contraindication

Beyfortus is contraindicated in infants and children with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab-alip or to any of the excipients.

Warnings and Precautions

  • Hypersensitivity Including Anaphylaxis: Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human IgG1 monoclonal antibodies. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, initiate appropriate medications and/or supportive therapy.
  • Use in Individuals with Clinically Significant 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%).

Click here to learn more about Sanofi’s commitment to fighting counterfeit drugs.