EMA Expedites Review for AstraZeneca’s Sipavibart

EMA Expedites Review for AstraZeneca's Sipavibart
EMA Expedites Review for AstraZeneca's Sipavibart. Credit | REUTERS

United States—AstraZeneca (AZN.L) announced on Monday that the European Union’s human medicines regulator has adopted a positive market authorisation application for its experimental COVID-19 prevention drug sipavibart for an expedited review.

The submission was made on the basis of the late-stage trial, in which it was suggested that the drug lowers the risk of infection in patients with lower immune system function, as reported by Reuters.

Accelerated Assessment for Public Health

“The EMA’s (European Medicines Agency) Committee for Medicinal Products for Human Use(CHMP) greenlighted sipavibart accelerated assessment as it was legally condemned of major interest for public health and therapeutic innovation,” the Anglo-Swedish drugmaker said.

An accelerated assessment refers to the attempt to have EMA’s review of a market authorization application become faster.

AstraZeneca’s Strategic Move

In May 2022, AstraZeneca will be in-licensed sipavibart from RQ Bio.

It is worth recalling that back in July, the company recalled its COVID-19 vaccine, one of the first and most popular at the time, due to the “abundance of new versions of COVID vaccines available” amid the pandemic, as reported by Reuters.