Sipavibart EMA submission accepted for accelerated COVID-19 prevention review

AstraZeneca has announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) for sipavibart under an accelerated assessment procedure. This investigational long-acting antibody is designed for the pre-exposure prophylaxis of COVID-19 in immunocompromised patients, who frequently do not respond adequately to vaccines and remain at high risk for severe outcomes from the virus.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted this accelerated assessment due to sipavibart's significant potential public health impact and therapeutic innovation. The accelerated assessment aims to shorten the review period for the MAA.

The application is supported by promising data from the SUPERNOVA Phase III trial, which confirmed sipavibart’s safety and efficacy in preventing symptomatic COVID-19 in immunocompromised patients. The trial was noteworthy in that it took place during a period when multiple SARS-CoV-2 variants were circulating, demonstrating the antibody’s effectiveness across different variants.

SUPERNOVA remains the only Phase III trial that specifically addresses pre-exposure prophylaxis for COVID-19 among immunocompromised patients exclusively. The trial results showed that sipavibart significantly reduced the incidence of symptomatic COVID-19 compared to a control group, which included either tixagevimab/cilgavimab or a placebo. Notably, all participants in the trial were immunocompromised due to various conditions such as hematologic malignancies, solid organ transplants, end-stage kidney disease requiring dialysis, or were on immunosuppressive treatments.

Professor Paul Loubet, a key investigator in the SUPERNOVA trial, emphasized the persistent high disease burden of COVID-19 among immunocompromised individuals. He noted that despite vaccinations, these patients remain disproportionately affected compared to the general population. With rising COVID-19 cases anticipated in the winter, sipavibart could be a crucial option for those who remain vulnerable.

Iskra Reic, Executive Vice President of Vaccines and Immune Therapies at AstraZeneca, highlighted the lack of adequate COVID-19 protection options for immunocompromised patients in Europe, who often find vaccination insufficient. She expressed satisfaction with the EMA's acceptance of the regulatory submission and the accelerated assessment procedure, affirming AstraZeneca’s commitment to making sipavibart available to these patients.

Data from this critical trial will be shared at an upcoming medical conference. AstraZeneca is also in talks with other regulatory bodies to explore potential authorisation pathways for sipavibart.

Despite the World Health Organization declaring an end to the pandemic, COVID-19 continues to pose significant risks to immunocompromised individuals. These patients, including those with blood cancers, organ transplants, or on dialysis, often have a weakened immune response to vaccines, placing them at elevated risk for severe disease outcomes.

The INFORM study, a large-scale real-world evidence project, highlighted that immunocompromised individuals bear a disproportionate burden of COVID-19. They constitute about 4% of the studied population but account for approximately 25% of COVID-19 hospitalizations, ICU admissions, and deaths, even after multiple vaccine doses.

Sipavibart (formerly known as AZD3152) is a long-acting monoclonal antibody designed to neutralize the interaction between the spike protein of SARS-CoV-2 and the host receptor ACE2. It was derived from B-cells donated by patients who had recovered from SARS-CoV-2 infection and engineered with the same antibody scaffold as Evusheld for enhanced potency and broad coverage across different variants.

Licensed by AstraZeneca in May 2022 from RQ Biotechnology, sipavibart aims to address the unmet medical needs of immunocompromised populations, potentially offering them a more effective shield against COVID-19.