AstraZeneca’s COVID prevention drug application gets EU fast-track assessment

(Reuters): AstraZeneca said on Monday that the European Union drug regulator has accepted a market authorisation application for its investigational COVID-19 prevention drug, sipavibart, for an accelerated assessment.

The submission was based on positive data from a late-stage trial that showed the drug reduced the risk of infection in patients with weaker immunity.

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

An accelerated assessment aims to speed up the EMA’s review of a market authorisation application.

AstraZeneca acquired sipavibart from RQ Bio in May 2022.

The drugmaker earlier this year withdrew its COVID-19 vaccine, one of the first and most widely used, due to “surplus of available updated vaccines” since the pandemic.