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FDA Declined Invivyd’s Request to Expand Existing Emergency Use Authorization of PEMGARDA™ (pemivibart) to Include Treatment of Mild-to-Moderate COVID-19 For Immunocompromised Persons Who Have No Alternative Therapeutic Options; No Change to the Exist...
FDA Declined Invivyd’s Request to Expand Existing Emergency Use Authorization of PEMGARDA™ (pemivibart) to Include Treatment of Mild-to-Moderate COVID-19 For
About this update from Invivyd, Inc.
[{"type":"text","content":"FDA Declined Invivyd’s Request to Expand Existing Emergency Use Authorization of PEMGARDA™ (pemivibart) to Include Treatment of Mild-to-Moderate COVID-19 For Immunocompromised Persons Who Have No Alternative Therapeutic Options; No Change to the Existing PEMGARDA EUA for Pre-Exposure Prophylaxis of COVID-19 in Certain Immunocompromised Patients \n FDA’s reasoning appears to center on a belief that COVID-19 treatment immunobridging analyses for a monoclonal antibody (mAb) must meet a standard of superior antiviral activity rather than equivalent antiviral activity to past, highly effective, previously authorized and now inactive COVID-19 mAbs in a bridging analysis of sVNA1 titer levels, otherwise the Agency is “unable to reasonably conclude that the known and potential benefits of pemivibart…outweigh the known and potential risks”Invivyd’s submission to expand the PEMGARDA™ EUA to include COVID-19 treatment for certain immunocompromised patients who have no other therapeutic options provided the FDA with analyses demonstrating comparable antiviral activity between pemivibart and adintrevimab, the key antibody of interest for immunobridging, as well as analyses demonstrating predicted pemivibart clinical efficacy in-line with prior authorized mAb therapeutics, and well above currently authorized convalescent plasmaIn parallel with continuing efforts with the FDA to advance PEMGARDA as a COVID-19 treatment for certain immunocompromised patients, Invivyd plans to rapidly advance VYD2311 in collaboration with FDA given the ongoing and unacceptable burden of COVID-19 in America, including high rates of death, hospitalization, and Long COVID, reflective of the short and modest disease protection from the current standard of care for vulnerable patient populationsThe COVID-19 treatment opportunity for pemivibart was not contemplated in existing financial guidance WALTHAM, Mass., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that Invivyd’s request to expand the existing emergency use authorization (EUA) for pre-exposure prophylaxis of COVID-19 EUA for PEMGARDA™ (pemivibart) to provide a treatment option for mild-to-moderate COVID-19 in adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions such as cancer and organ transplant, and for whom alternative COVID-...