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EMA speeds up review of AstraZeneca’s Sipavibart to stop Covid

Posted on by angelo
EMA speeds up review of AstraZeneca’s Sipavibart to stop Covid

In a phase III trial, the active ingredient was shown to be effective in preventing symptomatic Covid-19 in immunocompromised people. Credit: Andrii Vodolazhskyi / Shutterstock.

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

A long-acting antibody, sipavibart was designed to neutralize the interaction of the spike protein with the ACE2 receptor, providing protection against Omicron and other ancestral viral variants.

The antibody, developed by RQ Biotechnology in May 2022, was developed to protect immunocompromised people against Covid-19. These patients are at increased risk of severe outcomes from the disease.

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

The marketing authorisation application for sipavibart is based on the positive results from the phase III SUPERNOVA clinical trial.

This international, double-blind, randomized, placebo-controlled trial analyzed the efficacy and safety of sipavibart compared to control (tixagevimab/cilgavimab or placebo).

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

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

AstraZeneca is also working with other regulatory agencies to discuss potential pathways for authorization or approval of sipavibart.

Iskra Reic, Executive Vice President of Vaccines and Immune Therapies at AstraZeneca, said: “Immunocompromised patients currently have no options for protection against COVID-19 in Europe beyond vaccination, which is often not sufficient to protect them against the severe outcomes of COVID-19.

“We are pleased that the EMA has accepted this regulatory application under an accelerated assessment procedure and we will work to bring sipavibart to these extremely vulnerable patients.”