Remdesivir emergency approvals: a comparison of the U.S., Japanese, and EU systems
| Autor: | C Hasslboeck, Y Kishioka, Tania Teixeira, J Sato, Sandra L. Kweder, Agnes Saint-Raymond |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Compassionate Use Trials
Emergency Medical Services Coronavirus disease 2019 (COVID-19) Pneumonia Viral Marketing authorization Antiviral Agents 030226 pharmacology & pharmacy Betacoronavirus 03 medical and health sciences 0302 clinical medicine Japan Pandemic medicine Emergency medical services Humans media_common.cataloged_instance Pharmacology (medical) European Union General Pharmacology Toxicology and Pharmaceutics European union Drug Approval Pandemics media_common Alanine biology SARS-CoV-2 business.industry COVID-19 Compassionate Use General Medicine medicine.disease biology.organism_classification Adenosine Monophosphate United States COVID-19 Drug Treatment 030220 oncology & carcinogenesis Medical emergency Coronavirus Infections business |
| Zdroj: | Expert Review of Clinical Pharmacology |
| ISSN: | 1751-2441 1751-2433 |
| Popis: | There were no formal regulatory approvals for antivirals for the COVID-19 pandemic as of June 2020.We compare the first regulatory approvals for remdesivir, through emergency pathways available to three of the main regulators in the world, the U.S., Japan, and the EU. We look at the data supporting the decisions and how authorities exchanged information and collaborated to speed up approvals. Based only on topline data available as of 29 April 2020, regulators granted approvals to remdesivir based on very limited but robust data and waiting for more safety and efficacy data. This included the Emergency Use Authorization in the U.S. on 1 May, the Special Approval for Emergency in Japan on 7 May, and Compassionate Use (3 April) followed by a Conditional Marketing Authorization in Europe (Opinion 25th June, Decision (3 July)).While the regulatory approvals were clearly based on evidence, regulators used agile methods to speed up approval, and make the first antiviral with reliable data available to patients in their constituencies in a very short time frame. More data and wider patient access are still necessary for this product, and more treatments are needed for patients affected by COVID-19. |
| Databáze: | OpenAIRE |
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