Invivyd Submits Updated Immunobridging Data To FDA For PEMGARDA EUA Amendment
(RTTNews) - Invivyd, Inc. (IVVD), a biopharmaceutical company, on Monday announced the submission of an updated immunobridging analysis to the U.S. Food and Drug Administration or FDA in support of its Emergency Use Authorization or EUA amendment request for PEMGARDA or pemivibart, an investigational monoclonal antibody or mAb for the treatment of mild-to-moderate COVID-19 in immunocompromised patients. The updated analysis includes neutralization data for the current dominant SARS-CoV-2 variant XEC, showing that pemivibart exhibits significantly higher antiviral activity in the critical early phase after dosing compared to adintrevimab, the parent molecule.
The data also shows that pemivibart has promising antiviral activity compared to other monoclonal antibodies previously authorized for COVID-19 treatment.
PEMGARDA's safety profile, demonstrated in Invivyd's CANOPY Phase 3 clinical trial, further supports the request, with no additional reports of anaphylaxis after the drug's initial EUA authorization for pre-exposure prophylaxis or PrEP.
Invivyd has continued to provide timely updates to the FDA since its initial submission in July 2024.
The latest data builds on prior positive analyses, indicating pemivibart's consistent and effective antiviral action. If the EUA amendment is granted, Invivyd plans to initiate a clinical study in collaboration with the FDA to further assess pemivibart's virologic profile.
PEMGARDA is currently authorized for COVID-19 pre-exposure prophylaxis in certain immunocompromised individuals but has not yet been approved for treatment.
Currently, IVVD is trading at $0.45 down by 4.78%.
