Gilead gets US FDA's emergency use authorisation for remdesivir

Gilead Sciences on May 2 announced that the United States Food and Drug Administration (USFDA) has granted emergency use authorisation (EUA) for the investigational antiviral remdesivir to treat COVID-19.

Remdesivir is authorised for the treatment of hospitalised patients with severe COVID-19 disease. The optimal duration of treatment is still being studied in ongoing clinical trials. Under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of disease.

US President Donald Trump, on May 1, said that the FDA has granted Emergence Use Authorisation (EUA) for the investigational antiviral remdesivir.

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The authorization is temporary and does not take the place of the formal new drug application submission, review and approval process, the company said.

The EUA allows for the distribution and emergency use of remdesivir only for the treatment of COVID-19; remdesivir remains an investigational drug and has not been approved by FDA.

Allocation of the currently limited available supply of remdesivir will be made based on guiding principles that aim to maximise access for appropriate patients in urgent need of treatment, with direction from and in collaboration with the government.

The US government will coordinate 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.

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Gilead is working with the US 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," he added.