AstraZeneca Seeks Accelerated EU Review for COVID-19 Drug Sipavibart

AstraZeneca has announced that the European Union's drug regulatory agency has officially accepted the marketing authorization application for its investigational COVID-19 preventive drug, sipavibart. The acceptance marks the beginning of an accelerated assessment process. This step is based on promising late-stage clinical trial results, which indicate that sipavibart can significantly lower the risk of infection in patients with compromised immune systems.

The Anglo-Swedish pharmaceutical company highlighted that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted an accelerated assessment for sipavibart. This move is aimed at expediting the review process, thereby ensuring that the drug can be brought to market swiftly to address current healthcare needs and contribute to public health and therapeutic advancements.

AstraZeneca acquired sipavibart from RQ Bio in May 2022. Earlier this year, the company made the strategic decision to withdraw one of its widely used COVID-19 vaccines. This decision was made due to the oversupply of updated vaccines available during the pandemic. By doing so, AstraZeneca aims to optimize its resource allocation, allowing the company to concentrate on research and development in other critical areas.

The acceptance of sipavibart's marketing authorization application by the EMA and the subsequent accelerated assessment represent significant milestones. These steps underscore the importance of developing effective preventive treatments for COVID-19, especially for those with weakened immune systems who are at higher risk of severe illness.