AstraZeneca Reports the EMA’s Acceptance of MAA for Sipavibart Under Accelerated Assessment to Prevent COVID-19
Shots:
- The MAA was based on P-III (SUPERNOVA) study investigating the safety & efficacy of sipavibart vs control (tixagevimab/cilgavimab or PBO) to prevent COVID-19 in immunocompromised patients. AstraZeneca is planning approval pathways with regulatory authorities
- The study reached both the dual 1EPs incl. relative risk reduction of symptomatic COVID-19 caused by any SARS-CoV-2 variant and relative risk reduction of infections caused by SARS-CoV-2 variants without F456L mutation. Data will be highlighted at future conferences
- Sipavibart, a long-acting antibody, is developed to protect immunocompromised patients at high risk of serious COVID-19 outcomes and are unresponsive to vaccination alone
Ref: AstraZeneca | Image: AstraZeneca
Related News:- AstraZeneca Reports Results from the P-III (SUPERNOVA) Study of Sipavibart to Prevent COVID-19 in Immunocompromised Patients
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
