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FDA Panel Endorses AstraZeneca (AZN), Sanofi's RSV Antibody

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AstraZeneca (AZN - Free Report) and Sanofi (SNY - Free Report) announced that an FDA advisory committee recommended approving the company’s biologics license application (“BLA”) seeking approval for use of their respiratory syncytial virus (“RSV”) antibody Beyfortus (nirsevimab) in newborns and infants.

The FDA’s Antimicrobial Drugs Advisory Committee (“AMDAC”) voted unanimously (21-0), recommending Beyfortus as 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.

A final decision on the BLA is expected in third-quarter 2023. Though advisory committee recommendations are not binding on the FDA, they are taken into consideration before arriving at a final decision.

If approved with the designated time period, AstraZeneca/Sanofi expects to launch nirsevimab in the country during the 2023/2024 RSV season. Per the companies, the FDA indicated that it will expedite the BLA review timeline.

In the year so far, shares of AstraZeneca and Sanofi have increased 9.5% and 6.4%, respectively. During the same period, the industry has moved up 0.9%.

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The BLA is being supported by data from the comprehensive nirsevimab clinical development program, including the phase III MELODY study, the phase II/III MEDLEY study and multiple phase IIb studies. Data from these studies showed that single dose of the antibody demonstrated high, consistent and sustained efficacy and favorable safety against RSV disease.

Beyfortus was authorized in the European Union in November2022 to prevent RSV lower respiratory tract disease (“LRTD”) in newborns and infants during their first RSV season.

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.

Up until last month, there were no FDA-approved vaccines against RSV infections anywhere in the world. Last month, 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 lower respiratory tract disease (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. Last month, 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 decision from the FDA is expected this August.

Earlier this month, GSK announced that it also 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.

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AstraZeneca and Sanofi carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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