The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Gilead Sciences’ investigational antiviral drug, remdesivir, for hospitalized patients with severe COVID-19 disease. Also, Gilead has outlined its supply strategy for the drug.

An EUA is intended to provide availability of a medicine during an emergency; an EUA is not the equivalent of an FDA approval. Under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of disease. The authorization is temporary and does not take the place of the formal new drug application submission, review, and approval process. 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 the FDA.

Gilead says that the US government will coordinate the donation and distribution of remdesivir to hospitals in cities impacted most by COVID-19. Hospitals with intensive-care units and other hospitals that the US government deems most in need will receive priority in the distribution of remdesivir. Gilead says it 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.

The EUA is based on available data from two global clinical trials, the National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase III study in patients with moderate to severe symptoms of COVID-19, including those who were critically ill, and Gilead’s global Phase III study evaluating 5-day and 10-day dosing durations of remdesivir in patients with severe disease. Multiple additional clinical trials are ongoing to generate more data on remdesivir as a treatment for COVID-19.

Supply of remesdivir
Gilead says it has donated the entirety of its existing supply of finished and unfinished product. 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 authorizations and regulatory approvals, including the EUA. Gilead says it will continue to support clinical trials as well as expanded-access and compassionate-use programs for remdesivir. In addition, Gilead says it will evaluate global allocation of supply on an ongoing basis using multiple, independent data sources to track the incidence and severity of the outbreak.

Through process refinements, Gilead says it has shortened the manufacturing lead time from raw materials through to finished product. The typical timeline for manufacturing a drug such as remdesivir at scale is nine to 12 months, and Gilead says it has reduced that period to six to eight months.

Gilead has also supplemented internal manufacturing with 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 2020, one million treatment courses by December 2020, and millions more in 2021, if required. These goals were based on a 10-day treatment course. Gilead says it is building a geographically diverse consortium of pharmaceutical and chemical manufacturing companies to help reach and exceed manufacturing goals.

Source: Gilead Sciences