Invivyd's COVID Antibody PEMGARDA Retains Neutralization Power Against Key Variants, FDA Confirms
Invivyd's COVID Antibody PEMGARDA Retains Neutralization Power Against Key Variants, FDA Confirms
Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has re-issued an updated Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers (Fact Sheet) for PEMGARDA (pemivibart) to provide accurate in vitro neutralization activity of PEMGARDA against dominant circulating variants including KP.3.1.1 and LB.1.
致力於提供嚴重病毒性傳染病防護的生物製藥公司Invivyd, Inc.（納斯達克股票代碼：IVVD）今天宣佈，美國食品藥品監督管理局（FDA）已爲PEMGARDA（pemivibart）重新發布了最新的醫療保健提供商緊急使用授權（EUA）情況說明書（情況說明書），以提供PEMGARDA對主要循環變體的準確體外中和活性包括KP.3.1.1和Lb.1。
The FDA's newly updated Fact Sheet, dated September 26, 2024, removes a contested statement that "preliminary, non-peer-reviewed data in the public domain indicate that KP.3.1.1 may have substantially reduced susceptibility to pemivibart." The FDA has now included viral neutralization data for pemivibart that is in line with prior variants represented in the CANOPY Phase 3 clinical trial based on data generated by LabCorp's Monogram Biosciences lab and provided to the FDA on September 3, 2024, and determined that PEMGARDA is likely to retain adequate neutralization activity against SARS-CoV-2 variants currently circulating in the U.S., including KP.3.1.1 (FDA updates PEMGARDA's SARS-CoV-2 variant susceptibility data).
美國食品藥品管理局於2024年9月26日發佈的最新情況說明書刪除了一份有爭議的聲明，即 「公共領域未經同行評審的初步數據表明，KP.3.1.1可能已大大降低了對pemivibart的敏感性。」根據LabCorp的Monogram Biosciences實驗室生成並於2024年9月3日提供給美國食品藥品管理局的數據，美國食品藥品管理局現已納入pemivibart的病毒中和數據，該數據與CANOPY 3期臨床試驗中的先前變體一致，並確定PEMGARDA可能對目前在美國流通的SARS-CoV-2變體（包括KP.3.1.1）保持足夠的中和活性（美國食品藥品管理局更新 PEMGARDA）DA 的 SARS-CoV-2 變體易感性數據）。
Various laboratories, which may have competing or conflicting interests with Invivyd's core COVID-19 antibody business, may produce their own reagents meant to resemble pemivibart, and may put neutralization findings of unknown quality into the public domain. Invivyd, as a matter of policy and in partnership with the FDA, relies on the high standard of assessing authentic pemivibart under industrial-quality conditions to assess pemivibart neutralization potency and likely variant susceptibility. Such procedural rigor is critical given the difficulty of cellular bioassay development and validation and intrinsic quantitative variability of these assays even when conducted under highly controlled conditions. Invivyd encourages all stakeholders to rely on validated, scientific studies conducted with authentic pemivibart and to exercise caution when assessing the potential relevance of virology work performed under conditions of questionable quality and control.
可能與 Invivyd 的核心 COVID-19 抗體業務存在競爭或利益衝突的各種實驗室可能會自己生產類似於 pemivart 的試劑，並可能將質量未知的中和發現公之於衆。作爲一項政策，Invivyd與美國食品藥品管理局合作，依靠在工業質量條件下評估正宗pemivart的高標準來評估pemivbart的中和效力和可能的變種敏感性。鑑於細胞生物測定難以開發和驗證，而且即使在高度受控的條件下進行這些測定也具有內在的定量變異性，因此如此嚴格的程序至關重要。Invivyd 鼓勵所有利益相關者依賴經過驗證的、使用正宗的 pemivibart 進行的科學研究，並在評估在質量和控制可疑的條件下開展的病毒學工作的潛在相關性時謹慎行事。
