FDA Updates Pemgarda EUA Fact Sheet with Accurate SARS-CoV-2 Variant Susceptibility Data
核心洞察
The FDA updated the PEMGARDA™ EUA Fact Sheet to reflect accurate in vitro neutralization activity against dominant circulating variants KP.3.1.1 and LB.1.
The updated Fact Sheet removes a contested statement regarding potentially reduced susceptibility of KP.3.1.1 to pemivibart, based on data from LabCorp's Monogram Biosciences lab.
Invivyd continues active variant monitoring and asserts that PEMGARDA is likely to retain adequate neutralization activity against currently circulating SARS-CoV-2 (搜索) variants in the U.S.
Invivyd, Inc. (Nasdaq: IVVD) announced that the U.S. Food and Drug Administration (FDA) has re-issued an updated Emergency Use Authorization (EUA) Fact Sheet for PEMGARDA™ (pemivibart) to provide accurate in vitro neutralization activity data against dominant circulating SARS-CoV-2 (搜索) variants, including KP.3.1.1 and LB.1. The updated Fact Sheet, dated September 26, 2024, addresses previous concerns regarding the susceptibility of the KP.3.1.1 variant to pemivibart.
Correction of Previous Data
The FDA's updated Fact Sheet removes a contested statement that indicated KP.3.1.1 may have substantially reduced susceptibility to pemivibart based on preliminary, non-peer-reviewed data. The revision incorporates viral neutralization data for pemivibart, aligning with prior variants represented in the CANOPY Phase 3 clinical trial. This data, generated by LabCorp’s Monogram Biosciences lab and provided to the FDA on September 3, 2024, supports the conclusion that PEMGARDA is likely to retain adequate neutralization activity against SARS-CoV-2 (搜索) variants currently circulating in the U.S., including KP.3.1.1.
Importance of Validated Scientific Studies
Invivyd emphasizes the importance of relying on validated, scientific studies conducted with authentic pemivibart to assess neutralization potency and likely variant susceptibility. The company cautions against the use of neutralization findings of unknown quality that may be put into the public domain by various laboratories, some of which may have competing interests. According to Marc Elia, Chairman of the Invivyd Board of Directors, accurate and reliable industrial-grade applications of virology, using the actual pharmaceutical agent authorized for medical use, are central for healthcare professionals, patients, and other stakeholders to understand the risk-benefit profile of PEMGARDA.
PEMGARDA Overview
PEMGARDA™ (pemivibart) is a half-life extended investigational monoclonal antibody (mAb) engineered from adintrevimab. PEMGARDA targets the SARS-CoV-2 (搜索) spike protein receptor binding domain (搜索) (RBD), inhibiting virus attachment to the human ACE2 receptor (搜索) on host cells. It is authorized for emergency use by the U.S. FDA for the pre-exposure prophylaxis (prevention) of COVID-19 (搜索) in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise and are unlikely to mount an adequate immune response to COVID-19 vaccination. PEMGARDA is not authorized for the treatment or post-exposure prophylaxis of COVID-19 and is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.
Ongoing Variant Monitoring
Invivyd continues to actively monitor variants using validated methods and is not aware of any circulating variants not susceptible to PEMGARDA at this time. The company relies on extensive structural analysis and neutralization bioassays to assess variant susceptibility in partnership with the FDA, subject to the requirements in the PEMGARDA Letter of Authorization.