Whether these treatments will diminish the president’s battle with COVID-19 remains unknown and a source of unending speculation.
Despite the questions that remain regarding this situation, these two treatments have been making their way through the required safety and regulatory hurdles.
Neither drug is [FDA] approved. Remdesivir received emergency use authorization (EUA) from the FDA on May 1.
REGN-COV2 has not received EUA. The FDA allows “expanded access” (also called “compassionate use”) allowing patients with an “immediately life-threatening condition or serious disease or condition” to access investigational drugs, biologics, or medical devices for use outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Regeneron said it gave Trump REGN-COV2 under a compassionate use: “All we can say is that they asked to be able to use it, and we were happy to oblige,” Regeneron founder, president, and CEO Leonard S. Schleifer, MD, PhD, told The New York Times.