We are pleased to share with you that on October 22, 2020, The US Food and Drug Administration (FDA) approved the first drug to treat COVID-19: Veklury (remdesivir), an antiviral medicine manufactured by Gilead Sciences Inc. to be administered IV to patients needing hospitalization. Veklury-Remdesivir was originally developed to treat the Ebola virus, however, did not meet the efficacy endpoint in the Ebola clinical trial. In a large study led by the US National Institutes of Health (NIH), it was shown that the drug shortened the course of illness from an average of 15 days to about 10 days in hospitalized patients.
Veklury was submitted under the New Drug Application (NDA) track and granted a Fast Track designation by the FDA, which among other things, maximized the opportunities for Gilead to engage with the agency in its development of Veklury, for the treatment of COVID-19. Based on this designation, on April 6th, 2020, FDA granted Gilead’s request and accepted its proposal to allow for a rolling review of its development program for Veklury. Under this process, Gilead could submit the NDA sections for FDA review as they appear. Under traditional processes, the FDA’s review of an NDA does not begin until the sponsor has submitted the entire application to the Agency.
Notably, on the basis of the Department of Health and Human Services (HHS) determination that there is a public health emergency that involves the virus that causes COVID-19, and while Veklury was an investigational drug and not approved for any indication, the FDA issued (on February 2020) an Emergency Use Authorization (EUA) for emergency use of Veklury for the treatment of suspected or laboratory-confirmed COVID-19 patients. Emergency use authorization is NOT the same as FDA approval or licensure. EUAs do not remain in effect indefinitely and FDA is continuously evaluating the continued appropriateness of the EUA.
In summary, from the approval process of Veklury, we can learn that nowadays the FDA is committed to expediting the development and availability of COVID-19 treatments. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency is focusing on moving new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.
This Newsletter Prepared by:
Tsufit Gross, Ph.D
Pharma and Biotechnology project manager
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