The Food and Drug Administration granted emergency use authorization (EUA) for the drug Remdesivir to treat Covid-19. Is there currently a way for hospitals to access this medication or apply to receive it through the EUA?

Comment by InpharmD Researcher

Gilead, the producers of remdesivir, has transferred all supplies and authorization of use to the United States government which has yet to provide instructions to request the medication. Until further details of the EUA are worked out, the FDA states that remdesivir will still be available through: 1) Expanded Access Protocol (EAP); 2) emergency investigational new drug applications (EINDs) for pregnant women and children; and 3) Gilead’s randomized controlled trials (Part B is still enrolling for two trials).

Background

On May 1st, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for remdesivir use. The US government will be overseeing the distribution of remdesivir to hospitals in cities most heavily impacted by COVID-19. Given the severity of illness of patients appropriate for remdesivir treatment and the limited availability of drug supply, hospitals with intensive care units and other hospitals that the government deems most in need will receive priority in the distribution of remdesivir. [1], [2]

Until further details of the EUA are worked out, the FDA states that remdesivir will still be available through: 1) Expanded Access Protocol (EAP); 2) emergency investigational new drug applications (EINDs) for pregnant women and children; and 3) Gilead’s randomized controlled trials (Part B is still enrolling for two trials). [1], [2]

Gilead, the manufacturers for remdesivir, had previously allowed for compassionate use of remdesivir for pregnant women and children age <18 with COVID-19. However, according to a company statement (date of statement issue unknown), they have discontinued new requests for compassionate use to rapidly transition to emergency access program. [3], [4], [5]

Currently, there does not seem to be a way to enroll in their expanded access program from their website. A representative from Gilead confirmed that the responsibility of authorizing and supplying remdesivir to hospitals has been shifted to the United States government. There is currently no available information on how to access remdesivir through the governmental emergency access program. [3], [4], [5]

References:

[1] Food and Drug Administration. Remdesivir EUA Letter of Authorization. Available: https://www.fda.gov/media/137564/download. Published May 1, 2020. Accessed May 4, 2020.
[2] Food and Drug Administration. Frequently Asked Questions on the Emergency Use Authorization for Remdesivir for Certain Hospitalized COVID-19 Patients. https://www.fda.gov/media/137574/download. Published May 1, 2020. Accessed May 4, 2020.
[3] Gilead. Gilead Sciences Statement on Access to Remdesivir Outside of Clinical Trials. Available: https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-access-to-remdesivir-outside-of-clinical-trials. Accessed May 4, 2020.
[4] Clinicaltrials.gov. Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19). Available: https://clinicaltrials.gov/ct2/show/NCT04323761. Updated: April 30, 2020. Accessed May 4, 2020.
[5] Gilead. Gilead Sciences Update On The Company’s Ongoing Response To COVID-19. Available: https://www.gilead.com/purpose/advancing-global-health/covid-19. Updated April 29, 2020. Accessed May 4, 2020.