Remdesivir emergency approvals: a comparison of the U.S., Japanese, and EU systems. Issue 10 (2nd October 2020)

• Record Type: Journal Article
• Authors: Saint-Raymond, A; Sato, J; Kishioka, Y; Teixeira, T; Hasslboeck, C; Kweder, SL
• Is Part Of: Expert review of clinical pharmacology. Volume 13:Issue 10(2020)
• Page Start: 1095
• Page End: 1101
• Publication Date: 2020-10-02
• Subjects: Regulatory -- emergency use -- COVID-19 -- anti-viral -- marketing authorization -- compassionate use -- conditional marketing authorization; Clinical pharmacology -- Periodicals; 615.105
• DOI: 10.1080/17512433.2020.1821650
• Languages: English
• ISSNs: 1751-2433

Abstract

ABSTRACT: Introduction: There were no formal regulatory approvals for antivirals for the COVID-19 pandemic as of June 2020. Areas covered: 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)). Expert opinion: 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.