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The European Medicines Agency (EMA) has accepted AstraZeneca Plc's (NASDAQ:AZN) marketing authorization application for sipavibart for pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients.
AstraZeneca's application for sipavibart has been accepted under an accelerated assessment procedure.
Also Read: AstraZeneca Targets Ambitious $80B In Total Revenue By 2030 Through Pipeline Expansion.
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.
The EMA's 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 accelerated assessment aims to reduce the timeframe for the CHMP to review the marketing application compared to the standard procedure.
The application is based on results from the SUPERNOVA Phase 3 trial, which demonstrated sipavibart's safety and efficacy in preventing symptomatic COVID-19 in immunocompromised patients, compared to control, in a variant landscape in which COVID-19 cases captured throughout the trial were caused by several different SARS-CoV-2 variants.
High-level results from SUPERNOVA study showed that sipavibart demonstrated a statistically significant reduction in the incidence of symptomatic COVID‑19 compared to control (tixagevimab/cilgavimab or placebo) in an immunocompromised patient population.
The trial met both dual primary endpoints: relative risk reduction of symptomatic COVID-19 caused by any SARS-CoV-2 variant and the relative risk reduction of infections caused by SARS-CoV-2 variants not containing the F456L mutation.
In addition to the European Medicines Agency, AstraZeneca is in dialogue with other regulatory authorities on potential authorization or approval pathways for sipavibart.
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Price Action: AZN shares are up 0.09% at $78.06 at last check Monday.
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Posted In: AZN
