Health Canada has approved the use of remdesivir, a drug that is meant to treat severe COVID-19 symptoms.
The drug by Gilead Canada was given conditional authorization by Health Canada, and is the first approved treatment option for coronavirus in Canada.
According to a release, Veklury, also known as remdesivir, was created to treat coronavirus in adults and adolescents aged 12 years and older, and weighing at least 40 kg, who have pneumonia requiring supplemental oxygen.
Multiple trials around the world are currently evaluating the safety and efficacy of the drug in the treatment of coronavirus.
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“Based on available clinical data, remdesivir has been approved as a treatment for patients with severe COVID-19 in Japan, Taiwan, Hong Kong, India, Singapore, Australia, the United Arab Emirates and the European Union. Outside of these regions, remdesivir is an investigational, unapproved drug,” says a release from Gilead Canada.
The approval by Health Canada, according to their regulatory decision, was based on the interim analysis of a randomized, double-blind, placebo-controlled clinical trial.
“In an analysis performed after all patients had been followed up for 14 days, the median time to recovery in the overall population was 11 days in the Veklury group compared to 15 days in the placebo group,” reads the decision.
“The clinical benefit of Veklury was most apparent in patients receiving oxygen, but not on ventilation, at Day 1.”
According to Health Canada, the most common adverse reactions in the trial were increased transaminases, (which may cause liver damage) nausea, headache and rash.
“The efficacy and safety of Veklury in the treatment of COVID-19 have not been fully characterized at this time because the available clinical trial data are not comprehensive,” says the decision.
“However, given the high unmet medical need and emergency context of the COVID-19 pandemic, Health Canada considered the balance of benefit and harm for Veklury to be positive.”