The U.S. Food and Drug Administration has approved the antiviral drug remdesivir for treatment of COVID-19 in hospitalized patients, the first such treatment the FDA has authorized to fight the deadly coronavirus, Foster City-based drug company Gilead Sciences Inc. announced in a Thursday press release.
The drug, which is marketed under the name Veklury, works to stop replication of SARS-CoV-2, the virus that causes COVID-19, and it has been shown to shorten recovery from the illness by five days, the company stated.
The drug was previously authorized by the FDA only for emergency use. President Donald Trump was given the drug when he contracted COVID-19 earlier this month. With the approval, it is now widely available in hospitals across the country.
Veklury can be prescribed in the U.S. for adults and pediatric patients 12 years of age and older and weighing at least 88 pounds. It should only be administered in a hospital or in a health care setting that is providing treatment comparable to inpatient hospital care, according to the company.
Three randomized, controlled trials preceded the FDA approval, including a National Institute of Allergy and Infectious Diseases (NIAID) double blind, placebo-controlled Phase 3 ACTT-1 trial. That trial found that Veklury shortened patients' recovery time by five days compared to a placebo by five days. Patients who were on oxygen support saw their recovery improve by seven days compared to the placebo.
Veklury also reduced the progression of the disease in patients who needed oxygen, resulting in a significantly lower need for mechanical ventilation. Thirteen percent of patients who took Veklury needed to be put on mechanical ventilators compared to 23% who did not take the drug. Fewer patients also died after 29 days when taking Veklury compared with the placebo — 11.4% versus 15.2%.
"The approval of Veklury marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster and, in turn, helps preserve scarce health care resources," Dr. Barry Zingman, professor of Medicine at the Albert Einstein College of Medicine and Montefiore Medical Center, New York, said in the company's press release. "(It) provides hospitalized patients and their families important hope and offers health care providers a critical tool as they care for patients in need."
Daniel O’Day, chairman and CEO of Gilead Sciences, said, "It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need."
The most common adverse reactions that occurred in patients who received either a 5-day or 10-day treatment course of Veklury included low percentages of nausea and increased liver enzymes.
As for the availability of the drug, Gilead stated that as of Oct. 1 it was able to meet the demand in the United States and anticipated being able to meet global demand for Veklury this month as well, even in the event of potential future surges of COVID-19.
The FDA also issued a new Emergency Use Authorization (EUA) for using Veklury in hospitalized pediatric patients under 12 years of age. The authorization is temporary and may be revoked, the company said.
Find comprehensive coverage on the Midpeninsula's response to the new coronavirus by Palo Alto Online, the Mountain View Voice and the Almanac here.