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Sanofi (SNY), AstraZeneca's RSV Antibody Gets FDA Nod in Infants
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Sanofi (SNY - Free Report) and AstraZeneca (AZN - Free Report) announced that the FDA has approved theirlong-acting single-dose antibody Beyfortus (nirsevimab) for the prevention of lower respiratory tract disease (“LRTD”) caused by respiratory syncytial virus (“RSV”) in newborns and infants.
Following FDA’s approval, Beyfortus is the first monoclonal antibody approved to protect all infants through their first RSV season. The RSV antibody is also approved for use in children aged up to 24 months who are vulnerable to severe RSV disease through their second RSV season.
Sanofi and AstraZeneca plan to launch Beyfortus in the United States ahead of the upcoming 2023-24 RSV season.
The approval was expected, as last month, the FDA’s Antimicrobial Drugs Advisory Committee (“AMDAC”) voted unanimously (21-0), recommending Beyfortus as the first full immunization against RSV disease for all infants. The AMDAC also voted 19-2 supporting the antibody’s favorable benefit risk profile in children aged up to 24 months, who are vulnerable to severe RSV disease through their second RSV season.
The FDA approval and the AMDAC recommendation are based on data from three pivotal clinical studies — phase III MELODY study, phase II/III MEDLEY study and a phase IIb study. Data from these studies showed that single dose of Beyfortus demonstrated high, consistent and sustained efficacy and favorable safety against RSV disease.
Beyfortus received an authorization in the European Union last November to prevent RSV-induced LRTD in newborns and infants during their first RSV season.
In the year so far, shares of AstraZeneca and Sanofi have declined 10.4% and 5.1%, respectively. During the same period, the industry has lost 2.3%.
Image Source: Zacks Investment Research
Sanofi and AstraZeneca entered into an agreement in 2017 to develop and commercialize Beyfortus. Per the terms, AstraZeneca is responsible for development and manufacturing activities, while Sanofi is responsible for commercialization activities and record revenues.
Per the companies, RSV is the leading cause of hospitalization for infants under the age of one in the United States. In fact, nearly 75% of infants hospitalized for RSV are born healthy with no underlying conditions
Up until a couple of months back,there were no FDA-approved vaccines against RSV infections anywhere in the world. This May, the FDA approved two RSV vaccines developed by Pfizer (PFE - Free Report) and GSK (GSK - Free Report) , respectively, for older adults aged 60 years and older. These vaccines are to be marketed by Pfizer and GSK under the trade names Abrysvo and Arexvy, respectively.
Pfizer’s Abrysvo is currently under FDA review for preventing medically attended LRTD (“MA-LRTD”) and severe MA-LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals. In May 2023, an FDA advisory committee voted in favor of the RSV vaccine for infants. The committee believes the available data supports the efficacy and safety of the RSV vaccine. The committee voted 10 to 4 on safety and 14 to 0 on effectiveness. A final decision from the FDA is expected next month.
Last month, GSK received approval in the European Union for Arexvy in older adults aged 60 years and above. In the meantime, Pfizer’s RSV vaccine candidate is under review for older adults and maternal immunization in Europe.
Unlike vaccines which stimulate the immune system to produce antibodies, therapies like Beyfortus contain antibodies which are directly delivered into the bloodstream.
Image: Bigstock
Sanofi (SNY), AstraZeneca's RSV Antibody Gets FDA Nod in Infants
Sanofi (SNY - Free Report) and AstraZeneca (AZN - Free Report) announced that the FDA has approved theirlong-acting single-dose antibody Beyfortus (nirsevimab) for the prevention of lower respiratory tract disease (“LRTD”) caused by respiratory syncytial virus (“RSV”) in newborns and infants.
Following FDA’s approval, Beyfortus is the first monoclonal antibody approved to protect all infants through their first RSV season. The RSV antibody is also approved for use in children aged up to 24 months who are vulnerable to severe RSV disease through their second RSV season.
Sanofi and AstraZeneca plan to launch Beyfortus in the United States ahead of the upcoming 2023-24 RSV season.
The approval was expected, as last month, the FDA’s Antimicrobial Drugs Advisory Committee (“AMDAC”) voted unanimously (21-0), recommending Beyfortus as the first full immunization against RSV disease for all infants. The AMDAC also voted 19-2 supporting the antibody’s favorable benefit risk profile in children aged up to 24 months, who are vulnerable to severe RSV disease through their second RSV season.
The FDA approval and the AMDAC recommendation are based on data from three pivotal clinical studies — phase III MELODY study, phase II/III MEDLEY study and a phase IIb study. Data from these studies showed that single dose of Beyfortus demonstrated high, consistent and sustained efficacy and favorable safety against RSV disease.
Beyfortus received an authorization in the European Union last November to prevent RSV-induced LRTD in newborns and infants during their first RSV season.
In the year so far, shares of AstraZeneca and Sanofi have declined 10.4% and 5.1%, respectively. During the same period, the industry has lost 2.3%.
Image Source: Zacks Investment Research
Sanofi and AstraZeneca entered into an agreement in 2017 to develop and commercialize Beyfortus. Per the terms, AstraZeneca is responsible for development and manufacturing activities, while Sanofi is responsible for commercialization activities and record revenues.
Per the companies, RSV is the leading cause of hospitalization for infants under the age of one in the United States. In fact, nearly 75% of infants hospitalized for RSV are born healthy with no underlying conditions
Up until a couple of months back,there were no FDA-approved vaccines against RSV infections anywhere in the world. This May, the FDA approved two RSV vaccines developed by Pfizer (PFE - Free Report) and GSK (GSK - Free Report) , respectively, for older adults aged 60 years and older. These vaccines are to be marketed by Pfizer and GSK under the trade names Abrysvo and Arexvy, respectively.
Pfizer’s Abrysvo is currently under FDA review for preventing medically attended LRTD (“MA-LRTD”) and severe MA-LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals. In May 2023, an FDA advisory committee voted in favor of the RSV vaccine for infants. The committee believes the available data supports the efficacy and safety of the RSV vaccine. The committee voted 10 to 4 on safety and 14 to 0 on effectiveness. A final decision from the FDA is expected next month.
Last month, GSK received approval in the European Union for Arexvy in older adults aged 60 years and above. In the meantime, Pfizer’s RSV vaccine candidate is under review for older adults and maternal immunization in Europe.
Unlike vaccines which stimulate the immune system to produce antibodies, therapies like Beyfortus contain antibodies which are directly delivered into the bloodstream.
Sanofi Price
Sanofi price | Sanofi Quote
AstraZeneca PLC Price
AstraZeneca PLC price | AstraZeneca PLC Quote
Zacks Rank
Both Sanofi and AstraZeneca carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.