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An overview of the preclinical discovery and development of bamlanivimab for the treatment of novel coronavirus infection (COVID-19): reasons for limited clinical use and lessons for the future.
Tuccori, Marco; Convertino, Irma; Ferraro, Sara; Valdiserra, Giulia; Cappello, Emiliano; Fini, Elisabetta; Focosi, Daniele.
  • Tuccori M; Unit of Adverse Drug Reactions Monitoring, University Hospital of Pisa, Unit of Adverse Drug Reactions Monitoring, Pisa, Italy.
  • Convertino I; Department of Clinical and Experimental Medicine, Unit of Pharmacology and Pharmacovigilance, University of Pisa, Pisa, Italy.
  • Ferraro S; Department of Clinical and Experimental Medicine, Unit of Pharmacology and Pharmacovigilance, University of Pisa, Pisa, Italy.
  • Valdiserra G; Department of Clinical and Experimental Medicine, Unit of Pharmacology and Pharmacovigilance, University of Pisa, Pisa, Italy.
  • Cappello E; Department of Clinical and Experimental Medicine, Unit of Pharmacology and Pharmacovigilance, University of Pisa, Pisa, Italy.
  • Fini E; Department of Clinical and Experimental Medicine, Unit of Pharmacology and Pharmacovigilance, University of Pisa, Pisa, Italy.
  • Focosi D; Department of Clinical and Experimental Medicine, Unit of Pharmacology and Pharmacovigilance, University of Pisa, Pisa, Italy.
Expert Opin Drug Discov ; 16(12): 1403-1414, 2021 12.
Article in English | MEDLINE | ID: covidwho-1324534
ABSTRACT

Introduction:

In the COVID-19 pandemic emergency, research has been oriented toward the development of therapies that could cure critically ill patients and treatments that can reduce the number of hospitalized patients, in order to ease the pressure on health-care systems. Bamlanivimab, developed from human convalescent plasma, was the first monoclonal antibody to become available for emergency use in several countries. Expectations related to its use in COVID-19 patients as a single agent have been largely disregarded, especially against E484K-carrying SARS-CoV-2 variants.Areas covered In this drug discovery case history, the development of the drug is described starting from the identification and selection of the antibody, from the pre-clinical and clinical trials up to the post-authorization phase.Expert opinion Bamlanivimab has shown some efficacy in patients with mild to moderate COVID-19. Initially approved as a monotherapy, due to poor efficacy it is currently only usable in combination with etesevimab. Pharmacokinetic limitations and mainly the onset of SARS-CoV-2 variants are the main reasons for this limited clinical use. The use in preventing hospitalization also has ethical limits related to the sustainability of care, especially if, considering similar effectiveness, bamlanivimab is compared with convalescent plasma.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Neutralizing / Antibodies, Monoclonal, Humanized / Drug Development / COVID-19 Type of study: Prognostic study Topics: Variants Limits: Humans Language: English Journal: Expert Opin Drug Discov Year: 2021 Document Type: Article Affiliation country: 17460441.2021.1960819

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Neutralizing / Antibodies, Monoclonal, Humanized / Drug Development / COVID-19 Type of study: Prognostic study Topics: Variants Limits: Humans Language: English Journal: Expert Opin Drug Discov Year: 2021 Document Type: Article Affiliation country: 17460441.2021.1960819