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All About Remdesivir From IPA’s June 2020 Tech Tidbits newsletter
There are currently no drugs approved by the U.S. Food and Drug Administration (FDA) as safe and effective for the treatment of COVID-19. New research from the National Institutes of Health suggests that certain patients with COVID-19 may benefit from receiving the antiviral drug remdesivir. Gilead Sciences, the drug’s manufacturer, released initial study results from an ongoing Phase 3 clinical trial on April 29, 2020 suggesting that some patients with severe cases of COVID-19 experienced shortened time to recovery when treated with remdesivir. Two days after the initial research was released, the FDA issued an emergency use authorization (EUA) for remdesivir, enabling appropriate patients to more readily access the investigational drug.
What does the initial research show?
Gilead announced in a press release on April 29, 2020 that initial study results from an ongoing Phase 3 clinical trial, suggested that patients hospitalized with severe cases of COVID-19 who received remdesivir within 10 days of symptom onset were discharged from the hospital earlier than those treated beyond 10 days of symptoms.1 These early results also demonstrate the potential for some patients to be treated with a 5-day regimen of remdesivir. The treatment was generally well-tolerated with the most common side effects being nausea, worsening shortness of breath, and elevated liver enzymes.2 Gilead plans to share additional remdesivir data from the ongoing trial in the coming weeks. Is remdesivir approved for treatment of COVID-19? Remdesivir is considered an investigational drug because it is still being studied. Despite promising initial study results, it is too early to draw conclusions regarding the use of remdesivir in the treatment of COVID-19. Remdesivir has also not yet been approved for the treatment of any other condition by any regulatory authority. Its use in the United States is currently limited to emergency COVID-19 treatment situations. Clinical trials are ongoing while scientists and medical professionals around the world patiently await the final results.
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What is an EUA?
The FDA made remdesivir available under an EUA, or emergency use authorization, on May 1, 2020. This authorization allows the use of remdesivir, in emergency or life-threatening situations. Medical products made available under an EUA have not undergone the same extensive review process as an FDA-approved product. The FDA criteria to issue an EUA for a product are: • There are no adequate, approved, available alternatives. • It is reasonable to believe that the product may be effective. • The product meets standards for safety, performance, and labeling. • The potential benefits outweigh the potential risks of the drug’s use. • All of these criteria must be met to allow for a product to be used under an EUA. The EUA for remdesivir is set to remain in effect throughout the duration of the COVID-19 public health emergency unless new evidence suggests it should be terminated or revoked. Who can be treated with remdesivir? The FDA’s emergency use authorization of remdesivir permits treatment of hospitalized adult and pediatric patients with severe cases of COVID-19. The drug product is only available by Intravenous (IV) infusion. ■
References: 1. Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19. Gilead.com. https://www.gilead.com/news-and-press/press-room/pressreleases/2020/4/gilead-announces-results-from-phase-3-trialof-investigational-antiviral-remdesivir-in-patients-with-severecovid-19. Published 2020. Accessed June 5, 2020. 2. Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment. U.S. Food and Drug Administration. https://www.fda.gov/news-events/pressannouncements/coronavirus-COVID-19-update-fda-issuesemergency-use-authorization-potential-COVID-19-treatment. Published 2020. Accessed June 5, 2020. 3. Remdesivir Clinical Trials. Gilead.com. https://www.gilead.com/ purpose/advancing-global-health/covid-19/remdesivir-clinicaltrials. Published 2020. Accessed June 5, 2020
