Earlier this year, the drug had gained emergency use authorization (EUA), which falls short of approval but is given throughout a public health crisis if there is promoting data supporting its potential benefits. Approval determined the drug’s maker, Gilead, provided more information to the FDA on the medication’s effectiveness and safety than was used to issue the EUA.
“This decision by the FDA is a milestone in the treatment of hospitalized patients with COVID-19,” said Dr. Andre Kalil, professor of internal medicine at University of Nebraska Medical Center who was between the first to treat cases from the Diamond Princess Cruise ship with remdesivir and runs one of the drug’s clinical trials.
“Ramdev Sivir shortens the recovery time by 5-7 days, provides 50% faster clinical improvement, prevents patients’ progression to mechanical ventilation, and is associated with a 45% mortality reduction in the first two weeks of disease. These are real and meaningful benefits to our patients.”
The FDA conclusion is based on three randomized controlled experiments that found that people taking remedy decreased their recovery time. While the data did not find a statistically notable benefit in lessening mortality, doctors included in one of the studies, published in the New England Journal of Medicine (NEJM), reported a trend toward decreased mortality after about a month, particularly among people who got the drug early in their infection, as Kalil notes.
Patients taking the drug also needed less extra oxygen and were less likely to progress to severe disease as opposed to those receiving placebo. The NEJM study was placebo-controlled and supported by the U.S. National Institute of Allergy and Infectious Diseases.
The other two studies, sponsored by Gilead, did not introduce placebo controls, but compared patients receiving the drug and standard of care to those receiving standard of care alone. The medication was useful, and those receiving five days of ramdev sivir treatment improved as much as those getting a 10-day program.
The National Institutes of Health now includes remedy as part of its suggested treatment plan for hospitalized COVID-19 patients, and doctors treating patients have explained that the drug is one of the reasons that death rates from the disease may have begun to decline since the start of the pandemic. Other medicines and treatment strategies, such as anti-inflammatories and keeping patients on their stomachs to stop worsening respiratory symptoms, are other possible contributors to the decline in death rates.
The NEJM study introduced suggestions that people who get the drug earlier in their illness may benefit more, and doctors are already examining whether people with mild symptoms but who don’t need to be hospitalized can be managed with remdesivir on an outpatient basis.