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