AstraZeneca Submits COVID-19 Preventive Drug Sipavibart for Accelerated Review in the EU
VaccineEmergency Use AuthorizationAcquisition
AstraZeneca stated in a Monday announcement that the European Union's drug regulatory agency has formally accepted the marketing authorization application for its investigational COVID-19 preventive drug sipavibart, initiating an accelerated assessment process. This application was made based on positive late-stage clinical trial data, which showed the drug can significantly reduce the risk of infection in immunocompromised patients.
The Anglo-Swedish pharmaceutical company further noted: "The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted an accelerated assessment for sipavibart, aiming to expedite the importance of this drug in the areas of public health and therapeutic innovation." The accelerated assessment is intended to speed up the EMA's review of the marketing authorization application, ensuring the drug can be made available to the public as soon as possible to meet the healthcare needs.
AstraZeneca successfully acquired sipavibart from RQ Bio in May 2022. However, earlier this year, the company decided to withdraw one of its widely used COVID-19 vaccinesCOVID-19 vaccines due to the "oversupply of available updated vaccines" during the pandemic, in order to optimize resource allocation and focus on research and development in other critical areas.
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