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Law360 (May 1, 2020, 9:38 PM EDT ) The U.S. Food and Drug Administration on Friday gave the green light to Gilead's experimental antiviral drug remdesivir for treatment of COVID-19 patients, issuing an emergency use authorization that noted the drug was shown in a clinical trial to shorten the recovery time for some patients.
The headquarters of remdesivir-maker Gilead Sciences Inc. in Foster City, California. (AP)
The authorization comes two days after a National Institutes of Health trial showed promising results for the drug being developed by Gilead Sciences Inc., the FDA said, noting that there is still only "limited information known about the safety and effectiveness" of the treatment.
But based on that trial and a separate Gilead one, "it is reasonable to believe that the known and potential benefits of [remdesivir] outweigh the unknown and potential risks of the drug for the treatment of patients hospitalized with severe COVID-19," FDA Chief Scientist Denise M. Hinton wrote in the letter to Gilead approving its request.
In the statement, U.S. Department of Health and Human Services Secretary Alex Azar called the authorization "a significant step forward" in battling the disease, nodding to the NIH, FDA and scientists across the globe who've worked on the drug.
Under the emergency use authorization, remdesivir can be distributed in the U.S. and administered intravenously by health care providers when appropriate, the FDA said. It also requires that important information about using the drug — including dosing instructions, potential side effects and drug interactions — must be made available to health care providers and patients, the agency said.
Gilead on Friday said its limited supply of remdesivir will be allocated based on urgency, which it will determine with direction from the federal government. Hospitals in cities hit hardest by the coronavirus will be first on the list, the company said in its statement. Meanwhile, Gilead is working on scaling up its production, it said.
"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 said.
Gilead CEO Daniel O'Day said in the statement that the company and its international partners are continuing work on ongoing clinical trials to supplement their understanding of the drug.
"We are working to meet the needs of patients, their families and health care workers around the world with the greatest sense of urgency and responsibility," he said.
The company added in its statement that the optimal treatment duration is still being studied, but the FDA has approved both five-day and 10-day treatments.
Side effects could include increased levels of liver enzymes, which could indicate liver damage, and infusion-related reactions, like low blood pressure, nausea, vomiting, sweating and shivering, according to the FDA.
Both the FDA and Gilead emphasized that an emergency use authorization is not the same as FDA approval, which the drug still lacks. Emergency authorizations are intended to make a medicine available during an emergency, Gilead said. In determining whether to issue the emergency authorization, the FDA evaluated the available evidence and weighed the drug's known or potential risks with its known or potential benefits, the agency said.
The emergency use authorization will be effective indefinitely during the public health crisis, though it may be terminated or revised based on new information or changing circumstances, the FDA said.
In March, Gilead was granted orphan drug designation for remdisivir — a designation that would've given the company a seven-year monopoly on the treatment. But the company backed down and abandoned the designation following harsh backlash from public health groups, as well as Sen. Bernie Sanders, I-Vt.
Sanders said in a statement at the time that it was "not the time for profiteering in the pharmaceutical industry."
"Now is the time to bring our scientists together to develop and produce the best treatment for the coronavirus as quickly as possible," Sanders said.
Gilead has spent months evaluating the effectiveness of the drug. It's among a large group of companies attempting to develop a coronavirus vaccine. GeoVax Inc. and BravoVax Co. Ltd., as well as Regeneron Pharmaceuticals Inc. and Inovio Pharmaceuticals Inc., have also been working to develop a vaccine.
FDA Commissioner Stephen M. Hahn said in Friday's statement that the emergency authorization "is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective."
--Additional reporting by Kevin Stawicki. Editing by Nicole Bleier.
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