AstraZeneca (NASDAQ:AZN) said Monday its marketing authorization application for its investigational COVID-19 prevention drug, sipavibart, has been accepted for an accelerated assessment by the EU drug regulator.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use granted sipavibart accelerated assessment as it was deemed of major interest for public health and therapeutic innovation, the Anglo-Swedish drugmaker said in a statement.
The submission was based on positive data from a late-stage trial, in which the drug demonstrated a statistically significant reduction in the incidence of COVID‑19 in an immunocompromised patient population.
Sipavibart is an investigational long-acting antibody designed to provide COVID-19 protection for immunocompromised patients, who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.
In addition to the EMA, AstraZeneca (AZN) is in talks with other regulatory authorities on potential authorization or approval pathways for sipavibart.
AstraZeneca (AZN) initiated a worldwide withdrawal of its COVID-19 vaccine earlier this year, citing a “surplus of available updated vaccines”.
