The FDA this afternoon issued an emergency use authorization for the investigational antiviral drug remdesivir to treat severely ill COVID-19 patients.
The authorization for the drug, made by Gilead Sciences’ (NSDQ:GILD), will allow both adults and children to be treated with the remdesivir, the first drug believed to have any effect on the virus that has sickened millions and caused hundreds of thousands of deaths. Gilead said today that it aims to produce at least 500,000 treatment courses by October, 1 million treatment courses by December 2020 and millions more in 2021, if required.
Little is known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, but the investigational drug was shown in a federal clinical trial to shorten the time to recovery in some patients.
On Wednesday, the National Institutes of Health (NIH) revealed that the clinical trial showed that patients who received remdesivir had a 31% faster time to recovery from COVID-19 and of getting out of the hospital than those who received a placebo. Median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received a placebo. The results also suggested a survival benefit, with a mortality rate of 8% for the group receiving remdesivir versus 11.6% for the placebo group, the NIH noted.
Gilead conducted a separate, global clinical trial for the drug, evaluating 5-day and 10-day dosing durations of remdesivir in patients with severe disease. Multiple additional clinical trials are going on to generate more data on the safety and efficacy of remdesivir as a treatment for COVID-19, according to the company.
Remdesivir is an intravenous drug that normally takes months to produce, according to Gilead. Production also requires sterile drug product manufacturing capabilities, which limits the number of organizations capable of manufacturing the medicine. The company said today that it has substantially shortened the manufacturing lead time from raw materials through to finished product and supplemented internal manufacturing with significant additional capacity from multiple partners in North America, Europe and Asia.
Allocation of the currently limited available supply of remdesivir will be made based on guiding principles to maximize access for patients in urgent need of treatment, with direction from and in collaboration with the government, according to a news release from Gilead.
Under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of disease, the company added. The authorization is temporary and does not take the place of the formal new drug application submission, review and approval process.
The emergency use authorization allows for remdesivir to be distributed in the U.S. and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood-oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.
“This EUA opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of COVID-19,” said Gilead CEO Daniel O’Day in the news release. “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.”
In a separate statement, both U.S. Health and Human Services secretary Alex Azar and FDA commisioner Stephen Hahn called the EUA an important step in battling the pandemic.
“NIH, FDA, and scientists across America and around the world have worked tirelessly with patients to get us this new potential treatment for COVID-19,” Azar said.
“There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts,” added Hahn.
In making the decision to issue the EUA, the FDA concluded that “it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use,” the agency said.
Healthcare providers and patients will receive fact sheets about the drug, including dosing instructions, potential side effects and drug interactions. Possible side effects of remdesivir include: increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering, the agency said.