MedPath

Sanofi Ships Beyfortus in US to Protect Infants Against RSV

• Sanofi is shipping Beyfortus (nirsevimab-alip) doses in the US to help protect infants against RSV, aiming for equitable access through partnerships with government agencies. • The FDA approved a new Beyfortus filling line, expanding manufacturing capacity to meet anticipated demand for the 2024/2025 RSV season. • Beyfortus is the first and only long-acting monoclonal antibody approved for preventing RSV lower respiratory tract disease in newborns and infants. • RSV affects two out of three babies in their first year, leading to significant hospitalizations; Beyfortus offers fast-acting protection without immune system activation.

Sanofi has begun shipping doses of BEYFORTUS® (nirsevimab-alip) in the US to combat Respiratory Syncytial Virus (RSV) in infants. The company is collaborating with healthcare providers and the CDC to ensure availability ahead of the RSV season. This initiative aims to provide every eligible baby with access to immunization, whether born during or outside the RSV season.

Manufacturing Expansion

A new BEYFORTUS filling line has been approved by the FDA, which will significantly expand manufacturing capacity. This expansion is crucial to meet the anticipated demand for the 2024/2025 RSV season (November – March). AstraZeneca leads BEYFORTUS development and manufacturing, and Sanofi continues to work with them to build inventory for both current and future seasons.

Clinical Significance of Beyfortus

BEYFORTUS is the first and only long-acting monoclonal antibody approved for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants during their first RSV season, and for children up to 24 months who remain vulnerable through their second season. The single-dose antibody offers fast-acting protection without requiring activation of the immune system.

RSV Disease Burden

RSV is a highly contagious virus, with two out of three infants contracting it during their first year. It is the most common cause of LRTD, including bronchiolitis and pneumonia, in infants. In the US, an estimated 590,000 RSV cases in babies under one require medical care annually, making it a leading cause of hospitalization in this age group.

Sanofi's Commitment

Thomas Grenier, Head of Vaccines, North America, Sanofi, stated, "We're proud to offer BEYFORTUS doses to help protect every eligible baby in the US this RSV season... We look forward to BEYFORTUS offering its demonstrated real-world protection to as many infants as possible."
Sanofi has also launched the BEYFORTUS Reservation Program to gain insight into healthcare provider demand and prioritize fulfillment. The company continues to collaborate with government agencies to ensure readiness for the RSV season.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

FDA Approves Abrysvo for RSV Prevention in Adults Aged 18-59 at Increased Risk

The FDA has approved Abrysvo, Pfizer's RSV vaccine, for adults aged 18-59 at increased risk of RSV-associated lower respiratory tract disease.
Abrysvo is the first RSV vaccine approved for adults younger than 50, addressing a crucial need for at-risk individuals in this age group.

FDA Accepts Merck's Clesrovimab BLA for RSV Prevention in Infants

The FDA has accepted Merck's Biologics License Application (BLA) for clesrovimab, a long-acting monoclonal antibody, with a decision expected by June 10, 2025.
Clesrovimab aims to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season with a single-dose administration.

Sanofi Korea to Launch Beyfortus for RSV Prevention in Infants

Sanofi Korea will launch Beyfortus (nirsevimab) early next year to prevent RSV in infants, following its approval by the Ministry of Food and Drug Safety.
Clinical data from the MELODY phase 3 trial showed a 74.5% reduction in RSV-related lower respiratory tract infections requiring medical attention.

FDA Expands Approval of Pfizer's Abrysvo RSV Vaccine to At-Risk Adults Aged 18-59

The FDA has approved Pfizer's Abrysvo vaccine for adults aged 18-59 at increased risk of lower respiratory tract disease (LRTD) caused by RSV.
This decision is based on data from the Phase 3 MONeT trial, which demonstrated safety, tolerability, and immunogenicity in at-risk adults.

FDA Grants Fast Track Designation to Shionogi's Novel Anti-RSV Drug Candidate S-337395

The FDA has granted Fast Track designation to Shionogi's S-337395, a novel oral anti-RSV drug candidate, to expedite its development and review process.
S-337395 targets a protein essential for RSV replication, demonstrating a dose-dependent reduction of RSV in the lungs in preclinical trials.

FDA Approves Pfizer's Abrysvo RSV Vaccine for Adults 18-59 at Increased Risk

The FDA has approved Pfizer's Abrysvo vaccine for adults aged 18-59 at increased risk of RSV-related lower respiratory tract disease (LRTD).
Abrysvo is now the only RSV vaccine approved for this younger adult population, expanding its existing indications for older adults and pregnant women.

AyuVis' AVR-48 Receives FDA Fast Track for Preventing Bronchopulmonary Dysplasia

AyuVis Research Inc. received FDA Fast Track designation for AVR-48, a drug aimed at preventing bronchopulmonary dysplasia (BPD) in preterm infants.
AVR-48 targets the long-term inflammation and damage from oxygen treatments that lead to BPD, a major cause of mortality and complications in premature babies.

FDA Approves New Manufacturing Line for Sanofi and AstraZeneca's Beyfortus, Boosting RSV Protection for Infants

The FDA has approved a new manufacturing line for Sanofi and AstraZeneca's Beyfortus, an RSV antibody, to increase U.S. supply for the upcoming season.
Beyfortus is a long-acting monoclonal antibody that provides passive immunity against RSV in newborns and infants by blocking viral entry into host cells.

Sanofi Ships Beyfortus® in the U.S. to Protect Infants Against RSV

Sanofi is shipping Beyfortus (nirsevimab-alip) doses in the U.S. to healthcare providers and the CDC to protect infants against RSV.
The U.S. market is expected to have enough supply of Beyfortus for all eligible babies, ensuring access at regular checkups or birth.

FDA Panel Endorses AstraZeneca and Sanofi's RSV Drug for Infants

An FDA advisory panel has unanimously endorsed AstraZeneca and Sanofi's nirsevimab for preventing RSV in newborns and infants.
The long-acting monoclonal antibody, Beyfortus, requires only a single dose, potentially improving uptake and real-world efficacy.

Reference News

[1]
Sanofi shipping BEYFORTUS® in US to help protect babies against RSV disease
prnewswire.com · Sep 16, 2024

Sanofi ships BEYFORTUS doses to US healthcare providers and CDC for RSV prevention, ensuring access for eligible babies....

[2]
Sanofi readies to meet US demand for RSV antibody - BioPharma Dive
biopharmadive.com · Sep 16, 2024

Sanofi and AstraZeneca are shipping Beyfortus doses to the U.S. ahead of the RSV season, with FDA clearance for a new ma...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy