EMA accepts AstraZeneca’s regulatory submission for sipavibart for COVID-19 prevention

Betsy Goodfellow | July 1, 2024 | News story | Research and Development COVID-19, EMA, Infections and infestations, coronavirus 

AstraZeneca has announced that the European Medicines Agency (EMA) has accepted its Marketing Authorisation Application (MAA) for sipavibart under the accelerated assessment procedure, for the pre-exposure prophylaxis of COVID-19 in immunocompromised patients.

The drug is an investigational long-acting antibody designed to protect against COVID-19 for immunocompromised patients who often do not respond adequately to vaccination alone meaning they remain at a high risk of serious outcomes from the disease.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted the drug accelerated assessment due to it being of major interest for public health and therapeutic innovation.

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The MAA follows results from the phase 3 SUPERNOVA trial which demonstrated the drug’s safety and efficacy in prevented symptomatic COVID-19 in immunocompromised patients, compared to control.

Iskra Reic, executive vice president of vaccines and immune therapies at AstraZeneca, commented: “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.”

Betsy Goodfellow

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