Tuesday, July 16, 2024

Sipavibart Accepted for Accelerated EMA Assessment for COVID-19

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AstraZeneca’s Marketing Authorisation Application (MAA) for sipavibart, a long-acting antibody designed for the prevention of COVID-19 in immunocompromised patients, has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA). This accelerated assessment is granted due to the major public health interest and therapeutic innovation that sipavibart represents. The accelerated assessment aims to expedite the review process compared to the standard procedure.

The MAA submission 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. The trial showed a statistically significant reduction in the incidence of COVID-19 compared to the control group. This trial is particularly noteworthy as it is the only Phase III trial that provides efficacy data for COVID-19 pre-exposure prophylaxis exclusively in immunocompromised patients.

Promising Results for COVID-19 Prevention

Prof. Paul Loubet, a trial investigator from the University of Montpellier, emphasized the high disease burden of COVID-19 on immunocompromised patients, who are disproportionately impacted compared to the general population despite vaccination. With the anticipated rise in COVID-19 cases during the winter months, sipavibart could be a crucial option for these high-risk patients, providing protection in a mixed variant environment.

Iskra Reic, Executive Vice President of Vaccines and Immune Therapies at AstraZeneca, highlighted that immunocompromised patients in Europe currently have no options beyond vaccination for COVID-19 protection. The acceptance of the sipavibart regulatory submission with an accelerated assessment procedure is a significant step toward making this treatment available to vulnerable patients.

The SUPERNOVA trial included patients with various immunocompromising conditions, such as hematologic malignancies, solid organ transplants, hematopoietic stem cell transplants, end-stage kidney disease, and those receiving immunosuppressive treatments. Participants in the high-dose frexalimab group experienced a 41% reduction in plasma neurofilament light chain (NfL) levels from baseline after 48 weeks, indicating reduced nerve cell damage. Those in the low-dose group saw a 35% reduction, and similar reductions were observed in placebo groups that switched to frexalimab.


Potential for Immunocompromised Patients

Sipavibart was generally well-tolerated in the trial, with adverse events balanced between the control and treatment arms. These results reinforce the potential of sipavibart to provide meaningful protection against COVID-19 for immunocompromised patients.

AstraZeneca is also in discussions with other regulatory authorities regarding potential authorization or approval pathways for sipavibart. The positive high-level results from the SUPERNOVA trial demonstrated sipavibart’s efficacy in reducing the incidence of symptomatic COVID-19 caused by various SARS-CoV-2 variants. The trial met both primary endpoints, showing a significant reduction in the risk of symptomatic COVID-19 and infections caused by variants not containing the F456L mutation.


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Resource: AstraZeneca, July 01, 2024

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