Sipavibart receives EMA regulatory submission acceptance under accelerated assessment for teh rpevention of COVID-19

AstraZeneca’s Marketing Authorisation Application for sipavibart has now been accepted by the European Medicines Agency. This is for the pre-exposure prophylaxis of COVID-19 in immunocompromised patients.

Sipavibart is a 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.

This is based on the positive results from the SUPERNOVA Phase III 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 over the course of the trial were caused by several different SARS-CoV-2 variants. SUPERNOVA is still the only Phase III trial that provides efficacy data for COVID-19 pre-exposure prophylaxis exclusively in immunocompromised patients.

Prof. Paul Loubet, M.D., Ph.D., MPH, Professor of infectious diseases, University of Montpellier, head of the Infectious and Tropical Diseases department, Nîmes University Hospital, France, and SUPERNOVA trial investigator, said: “The disease burden of COVID-19 remains high for immunocompromised patients who are disproportionately impacted compared to the general population, despite vaccination. With cases expected to rise in the winter months, adding more pressure to stretched healthcare systems, sipavibart has the potential to be an important option for immunocompromised patients who remain at risk, and it has demonstrated COVID-19 protection in a mixed variant environment.”

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: “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.”

 

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Related Topics and Keywords

Covid-19, EMA, Sipavibart