U.S. FDA Staff Says In Documents That Sanofi/Astrazeneca's RSV Prevention Antibody Showed An Overall Favorable Safety Profile In Clinical Trials
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The US FDA staff reported that Sanofi and AstraZeneca's RSV prevention antibody demonstrated a favorable safety profile in clinical trials. However, 12 deaths were reported in pediatric patients who took the therapy, with 8 of them being unrelated to the study drug.
June 06, 2023 | 1:29 pm
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NEUTRAL IMPACT
AstraZeneca's RSV prevention antibody, developed with Sanofi, showed a favorable safety profile in clinical trials, but 12 pediatric deaths were reported.
The favorable safety profile is a positive sign for the drug's potential approval, but the reported pediatric deaths may raise concerns and require further investigation. This could lead to a neutral short-term impact on AstraZeneca's stock price.
CONFIDENCE 80
IMPORTANCE 60
RELEVANCE 50
NEUTRAL IMPACT
Sanofi's RSV prevention antibody, developed with AstraZeneca, showed a favorable safety profile in clinical trials, but 12 pediatric deaths were reported.
The favorable safety profile is a positive sign for the drug's potential approval, but the reported pediatric deaths may raise concerns and require further investigation. This could lead to a neutral short-term impact on Sanofi's stock price.
CONFIDENCE 80
IMPORTANCE 60
RELEVANCE 50