EU grants fast-track assessment to AstraZeneca’s COVID-19 prevention drug application
AstraZeneca has announced that the EU drug regulator has accepted a market authorisation app for Sipavibart, under an accelerated assessment.
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
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