EU grants fast-track assessment to AstraZeneca’s COVID-19 prevention drug application

AstraZeneca, who was in the news last month for their COVID-19 vaccine, has announced that the EU drug regulator has accepted a market authorisation application for its investigational COVID-19 prevention drug, Sipavibart, under an accelerated assessment.

According to the company’s press statement, the submission was based on positive data from a late-stage trial that showed the drug helped reduce the incidence of COVID-19 in immunocompromised patients.

As per a Yahoo Finance report, the Anglo-Swedish drugmaker said, “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 accelerated assessment aims to speed up the EMA's review of a market authorisation application.

AstraZeneca acquired Sipavibart from RQ Bio in May 2022