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Anti-SARS-CoV-2 hyperimmune globulin therapy - Grifols

Drug Profile

Anti-SARS-CoV-2 hyperimmune globulin therapy - Grifols

Latest Information Update: 06 Apr 2020

At a glance

  • Originator Grifols
  • Class Antivirals; Immunoglobulins
  • Mechanism of Action Immunomodulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Research COVID 2019 infections

Most Recent Events

  • 25 Mar 2020 Grifols entered into collaboration with Biomedical Advanced Research Development Authority and the Food and Drug Administration for the treatment of COVID-2019 infections
  • 25 Mar 2020 Early research in COVID-2019 infections in Spain (Parenteral)
  • 25 Mar 2020 Early research in COVID-2019 infections in USA (Parenteral)

Development Overview

Introduction

Anti-SARS-CoV-2 hyperimmune globulin therapy is being developed by Grifols in collaboration with United States Biomedical Advanced Research Development Authority (BARDA), the Food and Drug Administration (FDA) and other Federal public health agencies for the treatment of COVID-2019 infections. Company will use plasma from convalescent COVID-19 patients that will this specific plasma into a hyperimmune globulin. Early research is underway in the US and Spain.

Company Agreements

In March 2020, Grifols entered into a collaboration with the United States Biomedical Advanced Research Development Authority (BARDA), the Food and Drug Administration (FDA) and other Federal public health agencies to collect plasma from convalescent COVID-19 patients and to process this specific plasma into a hyperimmune globulin to support the preclinical and clinical studies to determine if anti-SARS-CoV-2 hyperimmune globulin therapy to treat COVID-19 disease. Grifols will volunteer its expertise and resources in the areas of plasma collection using its network of FDA-approved plasma donor centers; test and qualify donors in conjunction with other health agencies, to process plasma into hyperimmune globulin in its purpose-built facility. This unique collaboration will provide the opportunity to validate a therapy that, if proven effective, can be used today in the face of the COVID-19 pandemic and for future outbreaks of novel emerging viruses. [1]

Key Development Milestones

As of March 2020, Grifols is working on a clinical trial with inactivated plasma from recovered patients (methylene blue) through a collaboration with select donation centers and public hospitals for the treatment of COVID-2019 infections in Spain [1] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Antivirals, Immunoglobulins
  • Mechanism of Action Immunomodulators
  • WHO ATC code

    J06B (Immunoglobulins)

  • EPhMRA code

    J6H (Specific Immunoglobulins - Antiviral)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Research Spain, USA Parenteral / unspecified Grifols 25 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Grifols Originator Spain
Grifols Owner Spain
Food and Drug Administration Collaborator USA
Biomedical Advanced Research and Development Authority Collaborator USA

Development History

Event Date Update Type Comment
25 Mar 2020 Licensing Status Grifols entered into collaboration with Biomedical Advanced Research Development Authority and the Food and Drug Administration for the treatment of COVID-2019 infections [1] Updated 06 Apr 2020
25 Mar 2020 Phase Change Early research in COVID-2019 infections in Spain (Parenteral) [1] Updated 06 Apr 2020
25 Mar 2020 Phase Change Early research in COVID-2019 infections in USA (Parenteral) [1] Updated 06 Apr 2020

References

  1. Grifols Announces Formal Collaboration with US Government to Produce the First Treatment Specifically Targeting COVID-19.

    Media Release
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