Remdesivir has received emergency use authorization (EUA) from the U.S. Food and Drug Administration after a major study showed that it can reduce recovery time for hospitalized COVID-19 patients.
In a news release on Friday, the FDA said it has issued the EUA for “treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.”
The FDA acknowledged there is “limited information” so far about how effective or safe the drug is.
Preliminary results from a 1,063-patient clinical trial by the U.S. National Institutes of Health showed that patients given remdesivir recovered in a shorter than those given a placebo.
U.S. Health and Human Services Secretary Alex Azar hailed the FDA announcement as a “significant step” in the efforts to find a treatment for COVID-19, which so far has no approved treatment or vaccine.
An emergency use authorization by the FDA – which is temporary — is not the same as drug approval. An EUA is meant to provide access to medicine in an emergency.
Remdesivir is an experimental drug, delivered intravenously, that essentially works to inhibit an enzyme – polymerase – in the novel coronavirus that causes COVID-19.
As Dr. Matthias Gotte from the University of Alberta — who isn’t involved with the clinical trials — has previously explained to Global News, the enzyme is the engine of the virus that allows it to replicate and spread – and remdesivir works to stop that spread.
The full data from the U.S. has yet to go through peer review. Dr. Rob Fowler from Toronto’s Sunnybrook Hospital told Global News on Thursday that it’s too early to read into the results about remdesivir so far.
“I would say so far it’s hard to tell from results in the U.S., because we’re really waiting to see the full results and have some peer review of the findings,” he said.
Another study on remdesivir, out of China and based on a smaller number of patients, showed the drug did not shorten recovery time in critically ill patients. The authors of that study did warn that their findings were limited because the trial ended early — there weren’t enough patients once cases in China sharply decreased. The conclusion was that more evidence from clinical trials is necessary.
In a statement Friday, the drug manufacturer behind remdesivir – Gilead Science Inc. – noted the EUA is based on “available data from two global clinical trials.”
Ongoing clinical trials are still studying the “optimal duration of treatment.” The EUA allows for five-day and 10-day treatment durations, depending on how severe the disease is in a patient.
“The U.S. government will coordinate the donation and distribution of remdesivir to hospitals in cities most heavily impacted by COVID-19,” the company said in the statement.
Gilead has previously announced that it has donated its existing supply of “finished and unfinished product” – 1.5 million individual doses, for more than 140,000 treatment courses — to help combat the pandemic.
The company aims to produce at least half a million treatment courses by October 2020 and one million by the end of the year, according to Reuters.
During a meeting in the Oval Office with U.S. President Donald Trump, Gilead chief executive Daniel O’Day said the company would donate 1.5 million vials of the drug.
“We’re humbled by this being an important first step for … hospitalized patients. We want to make sure nothing gets in the way of these patients getting the medicine, so we made a decision to donate about 1.5 million vials,” he said.
The company’s Canadian division, Gilead Sciences Canada Inc., is in talks with Health Canada about remdesivir.
“Multiple studies are still ongoing to inform the safety and efficacy of this investigational drug,” the company said in an email Friday night.
“If supported by the data, our intent would be to seek expedited regulatory review and approval for remdesivir in Canada.”
— With files by Reuters
- Canadian man dies during Texas Ironman event. His widow wants answers as to why
- Invasive strep: ‘Don’t wait’ to seek care, N.S. woman warns on long road to recovery
- ‘Sciatica was gone’: hospital performs robot-assisted spinal surgery in Canadian first
- ‘Super lice’ are becoming more resistant to chemical shampoos. What to use instead
Comments