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Invivyd Provides Another Positive SARS-CoV-2 Variant Data Analysis to Satisfy U.S. FDA’s Gating Request for Completing Its Review of EUA Request for PEMGARDA™ (pemivibart) for the Treatment of Mild-to-Moderate COVID-19 in Certain Immunocompromised Pat...
Invivyd Provides Another Positive SARS-CoV-2 Variant Data Analysis to Satisfy U.S. FDA’s Gating Request for Completing Its Review of EUA Request for PEMGARDA™
About this update from Invivyd, Inc.
[{"type":"text","content":"Invivyd Provides Another Positive SARS-CoV-2 Variant Data Analysis to Satisfy U.S. FDA’s Gating Request for Completing Its Review of EUA Request for PEMGARDA™ (pemivibart) for the Treatment of Mild-to-Moderate COVID-19 in Certain Immunocompromised Patients \n Treatment immunobridging analysis, routinely updated for contemporary SARS-CoV-2 variants, compares pemivibart antiviral titers to adintrevimab antiviral titers from the company’s previous Phase 2/3 clinical trial of adintrevimab for the treatment of COVID-19 (STAMP), in which adintrevimab conferred a 66% to 74% reduction in risk of hospitalization or death from COVID-19 compared to placebo depending on time of therapy startMost recent updated analysis provided to FDA, incorporating current dominant SARS-CoV-2 variant XEC neutralization data, demonstrated substantially higher pemivibart titers in the critical early phase post-dosing (Days 0-5) as compared to adintrevimab Data provided to FDA includes supportive data showing attractive comparison of antiviral activity between pemivibart and monoclonal antibodies previously authorized for treatment of COVID-19Pemivibart safety profile demonstrated in the company’s CANOPY Phase 3 clinical trial supports the EUA amendment request; further, no additional reports of anaphylaxis have been identified during post-authorization use of PEMGARDA for COVID-19 pre-exposure prophylaxis (PrEP) to dateUpdated analysis builds upon multiple comparable analyses submitted to the FDA beginning July 2024 for prior SARS-CoV-2 variants, all showing consistent antiviral titer relationships and a favorable risk-benefit profile WALTHAM, Mass., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced the submission to the U.S. Food and Drug Administration (FDA) of an updated immunobridging analysis of pemivibart as ongoing support of a potential amendment to the Emergency Use Authorization (EUA) for pemivibart, a half-life extended investigational monoclonal antibody (mAb), to include the treatment of mild-to-moderate symptomatic COVID-19 in certain immunocompromised patients for whom alternative COVID-19 treatment options are not accessible or clinically appropriate. PEMGARDA™ (pemivibart) received an EUA from the FDA in March 20...