AstraZeneca’s application for sipavibart has been accepted by the European Medicines Agency (EMA) through an accelerated assessment procedure. This application is specifically for using sipavibart as a preventive treatment (pre-exposure prophylaxis) against Covid-19 in immunocompromised patients.
Sipavibart is an experimental long-acting antibody designed to protect immunocompromised patients from Covid-19. These patients often do not respond adequately to vaccines alone and are at higher risk of severe Covid-19 outcomes.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted sipavibart accelerated assessment due to its significant potential for public health benefit and therapeutic innovation. Accelerated assessment is aimed at shortening the review time for marketing authorization applications compared to standard procedures.
The application is supported by positive results from the SUPERNOVA phase III trial. This trial demonstrated that sipavibart is safe and effective in preventing symptomatic Covid-19 in immunocompromised patients compared to a control group. The trial took place in an environment where Covid-19 cases were caused by various SARS-CoV-2 variants, showing sipavibart’s efficacy across different viral strains.
Prof. Paul Loubet, who participated in the SUPERNOVA trial, highlighted the ongoing challenge of Covid-19 for immunocompromised patients, despite vaccination efforts. He emphasized sipavibart’s potential as an important option for these vulnerable patients, particularly with Covid-19 cases expected to rise during winter.
Iskra Reic, from AstraZeneca, noted the lack of Covid-19 protection options for immunocompromised patients in Europe beyond vaccination. She expressed satisfaction with the EMA’s acceptance of the regulatory submission under accelerated assessment and affirmed AstraZeneca’s commitment to making sipavibart available to these high-risk patients.
Detailed data from the SUPERNOVA trial will be presented at an upcoming medical conference. AstraZeneca is also engaged in discussions with other regulatory authorities regarding potential authorization pathways for sipavibart.
Despite the World Health Organization declaring the end of the pandemic a year ago, Covid-19 continues to pose a significant threat to immunocompromised individuals. These patients, including those with conditions like blood cancers, organ transplants, and autoimmune diseases, often have insufficient immune responses to vaccines, leaving them susceptible to severe Covid-19 outcomes.
The SUPERNOVA trial, a large global phase III study, evaluated sipavibart’s safety and efficacy compared to a control (tixagevimab/cilgavimab or placebo) in preventing Covid-19 in immunocompromised patients. It successfully demonstrated a statistically significant reduction in symptomatic Covid-19 cases compared to the control group, across various SARS-CoV-2 variants. The trial included participants with conditions such as hematologic malignancies, solid organ transplants, and kidney disease, who are at heightened risk of severe Covid-19 due to compromised immune systems.
Sipavibart was well-tolerated in the trial, with adverse events evenly distributed between the sipavibart and control groups. It is an investigational long-acting monoclonal antibody (LAAB) developed to neutralize the spike protein of SARS-CoV-2, providing broad coverage against both Omicron and earlier viral variants.
Derived from B-cells donated by recovered Covid-19 patients, sipavibart was engineered using a platform similar to Evusheld, with modifications to extend its half-life and reduce the risk of antibody-dependent enhancement of disease.
AstraZeneca acquired sipavibart from RQ Biotechnology in May 2022. As a global biopharmaceutical company, AstraZeneca focuses on discovering, developing, and commercializing prescription medicines across various therapeutic areas, including oncology, rare diseases, cardiovascular, renal & metabolism, respiratory & immunology.