First to the Finish Line! Remdesivir Becomes the First and Only FDA Approved Drug to Treat COVID-19

By Daniel Ojeda, Ph.D.

On October 22nd, Remdesivir (Veklury) was approved by the U.S. Food and Drug Administration (FDA) to treat patients with COVID-19. The approval comes days after the World Health Organization (WHO) reported that remdesivir provided little to no effect on overall mortality. The FDA based its decision on the ACTT-1 clinical trial results, where treatment with remdesivir reduced recovery time by an average of five days on hospitalized patients.

In a statement, Daniel O’Day, Chairman, and CEO of Gilead Sciences, said, “Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis. It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need”. He added, “The speed and rigor with which Veklury has been developed and approved in the U.S. reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. We will continue to work at speed with the aim of enhancing patient outcomes with Veklury to ensure all patients with COVID-19 have the best chance at recovery.”

Remdesivir

Developed by Gilead, remdesivir is a broad-spectrum antiviral drug that interferes with the virus’s ability to replicate. It has shown effectiveness in treating emerging viral pathogens such as Ebola, SARS, Marburg, MERS, and now SARS-CoV-2, the virus responsible for COVID-19.

Remdesivir was granted an Emergency Use Authorization by the FDA to back in May 2020 to treat hospitalized patients with severe disease. That authorization was expanded in late August to treat all patients of COVID-19 irrespective of the severity of their disease. Currently, remdesivir has been temporarily authorized in approximately 50 countries.

ACTT-1 and Solidarity Trials

ACTT-1, a double-blind, placebo-controlled, Phase 3 clinical trial for remdesivir, was sponsored by the National Institute of Allergy and Infectious Disease. Treatment with remdesivir resulted in patients recovering five days earlier than the patients receiving placebo treatment; however, there was no significant reduction in mortality. The approval today comes days after the release of the Solidarity clinical trial conducted by the WHO. This study enrolled almost 12,000 patients in over 30 countries. The results are still undergoing peer review; however, they reported that remdesivir did not lower mortality or delayed the need for assisted breathing on COVID patients.

These trials looked for different clinical outcomes. While both showed no effect in mortality, the reduction in recovery time, observed in the ACTT-1, is still a beneficial outcome; however, it is still unknown if the results of the solidarity trial will weight negatively for approval of remdesivir to treat COVID-19 patients in other member countries of the WHO. In the meantime, the solidarity clinical trial continues to evaluate other treatments that could reduce mortality.

Meeting the Demand

Gilead has scaled up production of remdesivir with more than 40 contract manufacturing organizations around the world. This allowed Gilead to meet the demand for the treatment in the U.S., and it is expected to meet global demand by the end of the month. Gilead is on track to produce more than 2 million treatment courses this year. Each treatment course lasts five days and uses six vials of the drug. The cost ranges from $2,340 to $3,120 in the U.S. The exact profit per treatment for Gilead is still unknown, but the company is due to report third-quarter earnings on October 28th, 2020, there we get an estimate of the profits remdesivir is set to produce for the company.

Related Article: COVID-19: Gilead’s Promising Remdesivir Data Jumps US Stocks, Hastens FDA’s Emergency Authorization Plans

References

1. https://www.gilead.com/news-and-press/press-room/press-releases/2020/10/us-food-and-drug-administration-approves-gileads-antiviral-veklury-remdesivir-for-treatment-of-covid19
2. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments
3. https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1.full.pdf+html
4. https://www.gilead.com/news-and-press/press-room/press-releases/2020/10/final-results-of-national-institute-of-allergy-and-infectious-diseases-actt-1-trial-published-in-new-england-journal-of-medicine-expand-clinical-bene
5. https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-broadens-emergency-use-authorization-veklury-remdesivir-include-all-hospitalized
6. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment

Author

Daniel Ojeda