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Ebanga™: The most recent FDA-approved drug for treating Ebola.

ABSTRACT: Ebolavirus (EBOV) is a virulent pathogen that causes Ebola virus disease (EVD), which is a life-threatening human condition with a fatality rate of up to 90%. Since the first outbreak in Africa in 1976, several outbreaks and epidemics of EBOV have occurred across the globe. While EVD is recognized as a serious threat to human health and outbreaks occur almost every year, the treatment options for the disease are limited. In designing therapeutic strategies against EBOV infection, viral structural proteins, such as glycoprotein (GP), could be an excellent target for neutralizing the virus. According to the latest research, GP-specific antibodies are the most efficient post-exposure treatments for EVD. Ansuvimab-zykl, i.e., mAb114 (Ebanga™), is a recent FDA-approved human immunoglobulin monoclonal antibody targeting EBOV GP. This review provides a brief overview of the pharmacological effects and safety profile of ansuvimab in clinical trials and provides insights into the precise mechanism of this new drug for treating EVD.

SUBMITTER: Taki E

PROVIDER: S-EPMC10032372 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Ebanga™: The most recent FDA-approved drug for treating Ebola.

Taki Elahe E Ghanavati Roya R Navidifar Tahereh T Dashtbin Shirin S Heidary Mohsen M Moghadamnia Marjan M

Frontiers in pharmacology 20230308

<i>Ebolavirus</i> (EBOV) is a virulent pathogen that causes Ebola virus disease (EVD), which is a life-threatening human condition with a fatality rate of up to 90%. Since the first outbreak in Africa in 1976, several outbreaks and epidemics of EBOV have occurred across the globe. While EVD is recognized as a serious threat to human health and outbreaks occur almost every year, the treatment options for the disease are limited. In designing therapeutic strategies against EBOV infection, viral st ...[more]

PMID: 36969842

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Project description:The unprecedented 2013-2016 West Africa Ebola outbreak accelerated several medical countermeasures (MCMs) against Ebola virus disease (EVD). Several investigational products (IPs) were used throughout the outbreak but were not conclusive for efficacy results. Only the Randomized Controlled Trial (RCT) on ZMapp was promising but inconclusive. More recently, during the second-largest Ebola outbreak in North Kivu and Ituri provinces, Democratic Republic of the Congo (DRC), four IPs, including one small molecule (Remdesivir), two monoclonal antibody (mAb) cocktails (ZMapp and REGN-EB3) and a single mAb (mAb114), were evaluated in an RCT, the Pamoja Tulinde Maisha (PALM) study. Two products (REGN-EB3 and mAb114) demonstrated efficacy as compared to the control arm, ZMapp. There were remarkably few side effects recorded in the trial. The FDA approved both medications in this scientifically sound study, marking a watershed moment in the field of EVD therapy. These products can be produced relatively inexpensively and can be stockpiled. The administration of mAbs in EVD patients appears to be safe and effective, while several critical knowledge gaps remain; the impact of early administration of Ebola-specific mAbs on developing a robust immune response for future Ebola virus exposure is unknown. The viral mutation escape, leading to resistance, presents a potential limitation for single mAb therapy; further improvements need to be explored. Understanding the contribution of Fc-mediated antibody functions such as antibody-dependent cellular cytotoxicity (ADCC) of those approved mAbs is still critical. The potential merit of combination therapy and post-exposure prophylaxis (PEP) need to be demonstrated. Furthermore, the PALM trial has accounted for 30% of mortality despite the administration of specific treatments. The putative role of EBOV soluble Glycoprotein (sGP) as a decoy to the immune system, the virus persistence, and relapses might be investigated for treatment failure. The development of pan-filovirus or pan-species mAbs remains essential for protection. The interaction between FDA-approved mAbs and vaccines remains unclear and needs to be investigated. In this review, we summarize the efficacy and safety results of the PALM study and review current research questions for the further development of mAbs in pre-exposure or emergency post-exposure use.

Project description:BackgroundAdverse Drug Reactions (ADRs) are of great public health concern. FDA-approved drug labeling summarizes ADRs of a drug product mainly in three sections, i.e., Boxed Warning (BW), Warnings and Precautions (WP), and Adverse Reactions (AR), where the severity of ADRs are intended to decrease in the order of BW > WP > AR. Several reported studies have extracted ADRs from labeling documents, but most, if not all, did not discriminate the severity of the ADRs by the different labeling sections. Such a practice could overstate or underestimate the impact of certain ADRs to the public health. In this study, we applied the Medical Dictionary for Regulatory Activities (MedDRA) to drug labeling and systematically analyzed and compared the ADRs from the three labeling sections with a specific emphasis on analyzing serious ADRs presented in BW, which is of most drug safety concern.ResultsThis study investigated New Drug Application (NDA) labeling documents for 1164 single-ingredient drugs using Oracle Text search to extract MedDRA terms. We found that only a small portion of MedDRA Preferred Terms (PTs), 3819 out of 21,920 or 17.42%, were observed in a whole set of documents. In detail, 466/3819 (12.0%) PTs were in BW, 2023/3819 (53.0%) were in WP, and 2961/3819 (77.5%) were in AR sections. We also found a higher overlap of top 20 occurring BW PTs with WP sections compared to AR sections. Within the MedDRA System Organ Class levels, serious ADRs (sADRs) from BW were prevalent in Nervous System disorders and Vascular disorders. A Hierarchical Cluster Analysis (HCA) revealed that drugs within the same therapeutic category shared the same ADR patterns in BW (e.g., nervous system drug class is highly associated with drug abuse terms such as dependence, substance abuse, and respiratory depression).ConclusionsThis study demonstrated that combining MedDRA standard terminologies with data mining techniques facilitated computer-aided ADR analysis of drug labeling. We also highlighted the importance of labeling sections that differ in seriousness and application in drug safety. Using sADRs primarily related to BW sections, we illustrated a prototype approach for computer-aided ADR monitoring and studies which can be applied to other public health documents.

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Ebanga™: The most recent FDA-approved drug for treating Ebola.

Publications

Ebanga™: The most recent FDA-approved drug for treating Ebola.

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