FDA grants remdesivir emergency use authorisation to treat COVID-19
The US FDA has given emergency use authorisation to remdesivir for the treatment of patients in hospital with severe COVID-19.
Gilead Sciences has announced that the US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for the investigational antiviral remdesivir to treat COVID-19.
According to the company, the EUA will facilitate broader use of remdesivir to treat hospitalised patients with severe COVID-19, enabling access to the drug at additional hospitals across the US. Allocation of the currently limited available supply of remdesivir will be made based on principles that aim to maximise access for appropriate patients in urgent need of treatment, with direction from and in collaboration with the government.
The company highlights that the authorisation is temporary and does not take the place of the formal new drug application submission, review and approval process.
The optimal duration of treatment with remdesivir is still being studied in ongoing clinical trials. Under the EUA, both five-day and 10-day treatment durations are suggested, based on the severity of disease.
The US government will co-ordinate the donation and 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. Gilead is working with the government on the logistics of remdesivir distribution and will provide more information when the company begins shipping the drug under the EUA.
“This EUA opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of COVID-19,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “We will continue to work with partners across the globe to increase our supply of remdesivir while advancing our ongoing clinical trials to supplement our understanding of the drug’s profile. We are working to meet the needs of patients, their families and healthcare workers around the world with the greatest sense of urgency and responsibility.”
The EUA is based on available data from two global clinical trials – the National Institute for Allergy and Infectious Diseases’ (NIAID) placebo-controlled Phase III study in patients with moderate to severe symptoms of COVID-19 and Gilead’s global Phase III study evaluating five-day and 10-day dosing durations of remdesivir in patients.
Gilead has donated the entirety of its existing supply of finished and unfinished remdesivir product to help address the urgent medical needs posed by the COVID-19 pandemic around the world. Assuming a 10-day treatment course, Gilead’s donation of 1.5 million individual doses of remdesivir equates to more than 140,000 treatment courses that will be provided at no cost to treat patients following potential emergency authorisations and regulatory approvals, including this EUA.
Gilead has invested significant capital to meet the supply needs for clinical trials and emergency treatment programmes of remdesivir and to prepare for even greater demand following regulatory authorisations, should these occur.
Through process refinements, the company has substantially shortened the manufacturing lead time from raw materials through to finished product. Gilead has also supplemented internal manufacturing with significant additional capacity from multiple partners in North America, Europe and Asia.
The company has set a goal of producing at least 500,000 treatment courses by October, one million treatment courses by December 2020 and millions more in 2021, if required – based on on a 10-day treatment course.