Remdesivir emergency approvals: a comparison of the US, Japanese and EU systems.

Remdesivir emergency approvals: a comparison of the US, Japanese and EU systems. Expert Rev Clin Pharmacol. 2020 Sep 10;: Authors: Saint-Raymond A, Sato J, Kishioka Y, Teixeira T, Hasslboeck C, Kweder SL 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 US, 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 April 29th, 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 US on May 1st, the Special Approval for Emergency in Japan on May 7th, and Compassionate Use (April 3rd) followed by a Conditional Marketing Authorization in Europe (Opinion 25th June, Decision (July 3rd). 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 on a very short time frame. More data and wider patient access are still necessary for this product, and more treatments are needed ...
Source: Expert Review of Clinical Pharmacology - Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research