Gilead’s Remdesivir receives emergency use authorization (EUA) from US Food and Drug Administration

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Gilead Sciences Inc.’s antiviral drug remdesivir was cleared by U.S. regulators for emergency use in Covid-19 patients, becoming the first medication backed by early clinical data to be made available to fight the novel coronavirus.

Remdesivir reduced the time it took hospitalized Covid-19 patients to recover in an interim analysis of an ongoing study. The Food and Drug Administration granted an emergency use authorization, President Donald Trump said on Friday, a step by which the agency can allow products to be used without full data on their safety and efficacy.

Gilead shares closed down 4.8% on Friday at $79.95 in New York. The company has faced questions from investors about how it plans to make money on the drug, but its stock is still up 23% this year, at a time when the rest of the market has cratered, reported Bloomberg.

“This was lighting speed in terms of getting something approved,” said FDA Commissioner Stephen Hahn, speaking with Trump. “From clinical trial to getting it authorized, it was 90 days.”

Remdesivir is authorized for the treatment of hospitalized 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. 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 FDA.

In a press release, the company announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the investigational antiviral remdesivir to treat COVID-19. The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease, enabling access to remdesivir at additional hospitals across the country. “Allocation of the currently limited available supply of remdesivir will be made based on guiding principles that aim to maximize access for appropriate patients in urgent need of treatment, with direction from and in collaboration with the government,” It added.

The U.S. 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. Gilead is working with the U.S. government on the logistics of remdesivir distribution and will provide more information when the company begins shipping the drug under the EUA.

As previously announced, Gilead has donated the entirety of its existing supply of finished and unfinished product to help address the urgent medical needs posed by this 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 authorizations and regulatory approvals, including this EUA. Gilead will continue to support clinical trials, and expanded access and compassionate use programs for remdesivir. In addition, Gilead will evaluate global allocation of supply on an ongoing basis using multiple, independent data sources to track the incidence and severity of the outbreak.

“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’ placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19, including those who were critically ill, and Gilead’s global Phase 3 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 the safety and efficacy of remdesivir as a treatment for COVID-19.

Remdesivir must be administered intravenously. The optimal dosing and duration of remdesivir for the treatment of COVID-19 is still unknown. Under this EUA, the 10-day dosing duration is suggested for patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO), and the 5-day dosing duration is suggested for patients not requiring invasive mechanical ventilation and/or ECMO. If a patient on the 5-day dosing duration does not demonstrate clinical improvement after five days, treatment may be extended for up to five additional days (10 days total).

Scale-Up of Remdesivir Supply

Gilead has aggressively implemented a multipronged approach to scale up production and rapidly build supply of the investigational antiviral remdesivir. The company has invested significant capital, at risk, to meet the supply needs for clinical trials and emergency treatment programs, and to prepare for even greater demand following regulatory authorizations, should these occur.

Through process refinements, Gilead 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, 1 million treatment courses by December 2020 and millions more in 2021, if required. These goals were based on a 10-day treatment course. Gilead now anticipates being able to cover significantly more patients based on the SIMPLE study results, which demonstrated similar efficacy with 5-day and 10-day dosing durations in patients with severe disease. Looking ahead, Gilead is building a geographically diverse consortium of leading pharmaceutical and chemical manufacturing companies to help reach and exceed manufacturing goals, and go above and beyond what any company could do individually. More details about these efforts are available here


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