Invivyd Updates PEMGARDA™ EUA Fact Sheet with Accurate SARS-CoV-2 Variant Data

Invivyd, Inc., a biopharmaceutical firm, has announced an updated Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers regarding their monoclonal antibody, PEMGARDA™ (pemivibart). This update, authorized by the U.S. Food and Drug Administration (FDA), aims to reflect accurate in vitro neutralization activity of PEMGARDA against key circulating SARS-CoV-2 variants such as KP.3.1.1 and LB.1, aligning with data from prior variants tested in Phase 3 clinical trials.

The revised Fact Sheet, dated September 26, 2024, rectifies an earlier statement suggesting that the variant KP.3.1.1 might show significantly reduced susceptibility to pemivibart. The current update includes viral neutralization data recorded by LabCorp's Monogram Biosciences lab, submitted to the FDA, indicating that PEMGARDA retains adequate neutralization activity against prevalent SARS-CoV-2 variants in the U.S. This change underscores the ongoing efficacy of PEMGARDA as reflected in the data from the CANOPY Phase 3 trial.

Marc Elia, Chairman of the Invivyd Board of Directors, emphasized the importance of rigorous, industrial-grade virology assessments using authorized pharmaceuticals to ensure healthcare professionals and patients have reliable information for decision-making. He highlighted that this update corrects prior confusion and reinforces the need for high-quality, validated scientific studies.

PEMGARDA, an investigational monoclonal antibody engineered from adintrevimab, targets the SARS-CoV-2 spike protein receptor binding domain (RBD). This mAb is designed to inhibit the virus's attachment to the ACE2 receptor on human cells. PEMGARDA has shown in vitro neutralizing activity against significant SARS-CoV-2 variants, including JN.1.

Approved under an EUA for pre-exposure prophylaxis of COVID-19, PEMGARDA is intended for use in adults and adolescents with moderate-to-severe immune compromise who are unlikely to respond adequately to COVID-19 vaccination. Users should not be infected with or recently exposed to COVID-19. PEMGARDA is not authorized for treating COVID-19 or for post-exposure prophylaxis. It is also not a vaccine substitute but an additional preventative measure for specific populations.

Anaphylaxis has been recorded as a potential adverse reaction, and the Fact Sheet includes a boxed warning for this condition. Common side effects range from infusion-related and hypersensitivity reactions to upper respiratory tract infections, viral infections, and influenza-like symptoms.

The EUA for PEMGARDA was supported through an immunobridging approach, comparing the neutralizing titers of PEMGARDA with those of previously authorized mAbs against SARS-CoV-2. While the EUA provides a rapid response to emerging variants, it comes with limitations due to the evolving nature of the virus and the varied efficacy of neutralizing antibodies in different clinical settings. The authorization is valid as long as the frequency of variants with reduced susceptibility to PEMGARDA remains below a specified threshold.

Invivyd continues to monitor SARS-CoV-2 variants using validated methods to ensure the ongoing efficacy of PEMGARDA against circulating strains. The company's INVYMAB™ platform combines viral surveillance, predictive modeling, and antibody engineering to generate new mAbs to tackle evolving viral threats. This platform underscores Invivyd’s commitment to developing innovative solutions for serious viral infectious diseases, starting with SARS-CoV-2.

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