Sipavibart EMA Regulatory Submission Approved for Accelerated Assessment in COVID-19 Prevention

AstraZeneca’s Marketing Authorisation Application (MAA) for sipavibart has been accepted under the accelerated assessment procedure by the European Medicines Agency (EMA) for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients.

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 (CHMP) granted sipavibart accelerated assessment as it was deemed of major interest for public health and therapeutic innovation. Accelerated assessment aims to reduce the timeframe for the CHMP to review an MAA compared to the standard procedure.

The MAA is based on 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 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 at the University of Montpellier, head of the Infectious and Tropical Diseases department at 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 of Vaccines and Immune Therapies at 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.”

Data from the SUPERNOVA trial will be presented at an upcoming medical meeting.

In addition to the EMA, AstraZeneca is in dialogue with other regulatory authorities on potential authorization or approval pathways for sipavibart.

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