Unanimous Support for AstraZeneca and Sanofi's Nirsevimab: Next Generation RSV Treatment on the Horizon
Portfolio Pulse from Vandana Singh
The FDA's Antimicrobial Drugs Advisory Committee has unanimously voted in favor of AstraZeneca and Sanofi's nirsevimab for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants. The FDA accepted the marketing application for nirsevimab in 2022, and it could be available in the US before the 2023-2024 RSV season.
June 09, 2023 | 12:07 pm
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POSITIVE IMPACT
AstraZeneca's nirsevimab receives unanimous support from FDA committee for RSV prevention in newborns and infants, potentially available before 2023-2024 RSV season.
The unanimous support from the FDA committee for AstraZeneca's nirsevimab indicates a high likelihood of approval, which could lead to increased revenues and a positive impact on the stock price in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100
POSITIVE IMPACT
Sanofi's nirsevimab receives unanimous support from FDA committee for RSV prevention in newborns and infants, potentially available before 2023-2024 RSV season.
The unanimous support from the FDA committee for Sanofi's nirsevimab indicates a high likelihood of approval, which could lead to increased revenues and a positive impact on the stock price in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100
NEGATIVE IMPACT
Swedish Orphan Biovitrum's Synagis is currently the only approved preventive therapy for RSV in the US, but nirsevimab's potential approval could introduce competition.
If nirsevimab is approved, it could introduce competition for Swedish Orphan Biovitrum's Synagis, potentially affecting the company's market share and revenues, leading to a negative impact on the stock price in the short term.
CONFIDENCE 80
IMPORTANCE 60
RELEVANCE 50