In a Phase III trial, the asset was demonstrated to be effective in preventing symptomatic Covid-19 in immunocompromised individuals. Credit: Andrii Vodolazhskyi / Shutterstock.

The European Medicines Agency (EMA) has accepted AstraZeneca‘s marketing authorisation application for sipavibart as Covid-19 pre-exposure prophylaxis (preventive treatment) in immunocompromised patients, under an accelerated assessment approach.

A long-acting antibody, sipavibart has been designed to neutralise the spike protein interaction with the ACE2 receptor, providing protection from Omicron and other ancestral viral variants.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Licensed from RQ Biotechnology in May 2022, the antibody has been developed to safeguard immunocompromised individuals from Covid-19. These patients are at a heightened risk of severe outcomes from the disease.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted sipavibart an accelerated assessment due to its potential for public health and as a therapeutic innovation.

The submission for sipavibart is based on the positive outcomes from the Phase III SUPERNOVA clinical trial.

This international, double-blind, randomised, placebo-controlled trial analysed the efficacy and safety of sipavibart versus control (tixagevimab/cilgavimab or placebo).

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The variants of Covid-19 observed during the trial included several different SARS-CoV-2 strains.

Sipavibart prevented symptomatic Covid-19 in immunocompromised individuals versus the control group.

AstraZeneca is also engaging with other regulatory bodies to discuss potential authorisation or approval pathways for sipavibart.

AstraZeneca vaccines and immune therapies executive vice-president Iskra Reic stated: “Immunocompromised patients currently have no options for Covid-19 protection in Europe beyond vaccination, which often is not sufficient to protect them against serious Covid-19 outcomes.

“We are pleased that the EMA has accepted this regulatory submission with an accelerated assessment procedure and will work to bring sipavibart to these highly vulnerable patients.”