Gilead's Research Antiviral Remdesivir receives US Food and Drug Administration Emergency Use Permission for COVID-19 Treatment
Authorization Makes broader use of Remdesivir in the United States for treating hospitalized patients with severe COVID-19 disease, and depending on the severity of the patient's illness, authorization Includes 5 days to 10 days of treatment
May 1, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) announced that US. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the COVID-19 treatment of antiviral investigational remdesivir. The EUA would encourage wider use of remdesivir to treat patients with serious COVID-19 disease in hospital, allowing for access to remdesivir in additional hospitals around the world. Allocation of the currently restricted supply of remdesivir will be made on the basis of guiding principles aimed at optimizing access for suitable patients in urgent need of care, with input from and in cooperation with the government.
Remdesivir is approved for the treatment of severe COVID-19 disease in hospitalized patients. Ongoing clinical trials are also researching the appropriate period of treatment. Under the EUA, treatment durations of both 5 days and 10 days are recommended, depending on the nature of the disease. The authorization is temporary and will not take the place of the referral, evaluation and approval process of the formal new product application. The EUA approves remdesivir for distribution and emergency use only for COVID-19 treatment; remdesivir remains an investigational drug and has not been approved by FDA.
The U.S. government will coordinate the donation and distribution of remdesivir to hospitals in cities most seriously impacted by COVID-19. Considering the seriousness of patients' disease suitable for treatment with remdesivir and the restricted availability of drug supply, hospitals with intensive care units and other hospitals which the government considers most in need will receive priority in the distribution of remdesivir. Gilead is working on remdesivir delivery logistics with the U.S. government, and will provide more information when the company begins shipping the drug under the EUA.
The EUA is based on available evidence from two global clinical trials – the placebo-controlled Phase 3 study of the National Institute for Allergy and Infectious Diseases in patients with mild to severe COVID-19 symptoms, including those with serious illness, and the Global Phase 3 study of Gilead testing 5-day and 10-day dosing durations of remdesivir in patients with severe illness. There are several additional clinical trials underway to produce more data on the safety and efficacy of remdesivir as a COVID-19 drug.
Remdesivir requires intravenous administration. The optimal dose and length of remdesivir is still unknown for treating COVID-19. Within this EUA, for patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO), the 10-day dosing period is recommended, and the 5-day dosing period is recommended for patients not needing intrusive mechanical ventilation and/or ECMO. If a patient shows no clinical progress after five days on the 5-day dosing cycle, treatment can be extended for up to five additional days (total of 10 days).
Gilead has successfully adopted a multi-pronged approach to maximize production and quickly build up the antiviral investigational remdesivir market. The organization has invested significant, at-risk resources to meet the supply needs for clinical trials and emergency response services, and to plan for even greater demand following regulatory approvals should these occur.
