Gilead Sciences has secured the US Food and Drug Administration (FDA) emergency use authorisation (EUA) for its investigational antiviral product remdesivir to treat Covid-19.
The company said that the FDA authorisation will enable the use of remdesivir for treating hospitalised patients with severe Covid-19 disease, at additional hospitals across the country.
Also, the EUA suggests both five-day and 10-day treatment durations based on the severity of disease and the optimal duration of treatment will be through ongoing clinical trials.
The EUA suggests the 10-day dosing duration for patients requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), and the five-day dosing duration for patients not requiring invasive mechanical ventilation and/or ECMO.
Gilead Sciences chairman and chief executive officer Daniel O’Day said: “This EUA opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of Covid-19.
“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 FDA granted EUA for remdesivir based on two Phase 3 clinical trials
The company said that the availability of remdesivir is currently limited, and is planning to allocate the supply for appropriate patients in need of treatment, with direction from and the government.
Also, the US government would coordinate the donation and distribution of remdesivir to hospitals in cities that are highly impacted by Covid-19.
Since the illness of patients is severe and the drug supply is limited, hospitals with intensive care units and other hospitals that are most in need will receive priority in the distribution of remdesivir. Gilead is working with the US government on the logistics of remdesivir distribution.
The US regulatory agency has granted the EUA, based on data from two global clinical trials.
The National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study in patients with moderate to severe symptoms of Covid-19, is the first trial, and Gilead’s global Phase 3 study of remdesivir evaluating five-day and 10-day dosing durations is the second one.
Various other clinical trials are also being conducted to generate more data on the safety and efficacy of remdesivir as a treatment for Covid-19, said the company.
