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.
Invivyd, Inc. (納斯達克:IVVD)，一家專注於提供針對嚴重病毒性傳染病的保護的生物製藥公司，今天宣佈，美國食品藥品監督管理局（FDA）重新發布了有關PEMGARDA（pemivibart）針對主要流行變體KP.3.1.1和Lb.1進行準確體外中和活性的緊急使用授權（EUA）醫療提供者事實說明書（Fact Sheet）。
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).
美國食品藥品監督管理局（FDA）新更新的Fact Sheet，日期爲2024年9月26日，刪除了一個有爭議的聲明，即"公共領域中初步的非同行評審數據表明KP.3.1.1對pemivibart的敏感性可能大幅降低"。FDA現在已經包括了針對pemivibart的病毒中和數據，這些數據與CANOPY第3期臨床試驗中先前變體中呈現的數據一致，由LabCorp的Monogram Biosciences實驗室於2024年9月3日生成並提供給FDA，並確定PEMGARDA可能保留對當前在美國流行的SARS-CoV-2變體，包括KP.3.1.1的足夠中和活性（FDA更新PEMGARDA的SARS-CoV-2變體敏感性數據）。
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.
可能具有競爭或衝突利益的各實驗室在公共領域中可能會生產類似pemivibart的試劑，並可能將未知質量的中和發現公之於衆。作爲政策問題，並與FDA合作，Invivyd 依賴於高標準的工業質量條件下評估真正的pemivibart的方式來評估pemivibart的中和效力和可能的變體敏感性。在細胞生物分析法的開發和驗證存在困難以及在高度受控條件下進行這些分析時的內在定量變異性的情況下，這種程序嚴密是至關重要的。Invivyd 鼓勵所有利益相關者依賴於通過驗證的科學研究進行的真實pemivibart研究，並在評估在質量和控制條件具有疑問性的情況下進行的病毒學工作的潛在相關性時要小心。
譯文內容由第三人軟體翻譯。