The federal government has approved a new drug to treat COVID-19 patients who are so sick they require additional oxygen
Remdesivir, which goes by the brand name Veklury, was approved for use by Health Canada Tuesday. While clinical trials using the drug are still ongoing, early studies suggest it might improve the prospects of patients diagnosed with COVID-19 who are treated for pneumonia. The drug is only for use in the most extreme circumstances, and not for patients who only have mild symptoms. Further, the drug is in short supply, and while the federal government is attempting to obtain it for use in Canada, it could be difficult to obtain as it is in high demand around the world.
According to a regulatory decision posted to the Health Canada website Tuesday, while one double-blind placebo-controlled study showed some success for patients receiving oxygen, other studies had deficiencies or low enrollment, and clinical proof-of-concept for antiviral activity has not been established.
Still, Health Canada said, the drug was generally well-tolerated, with the most common side effects being nausea, headache, rash and higher-than-usual levels of a family of enzymes in the liver that can indicate liver inflammation.
“The efficacy and safety of Veklury in the treatment of COVID-19 have not been fully characterized at this time … 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.
The drug, the ruling wrote, will be allowed for the treatment of COVID-19 in adults and adolescents aged 12 or older with pneumonia requiring supplemental oxygen.
“Health Canada did approve with condition … a drug for the treatment of the most severe clinical presentations of COVID-19,” explained Dr. Theresa Tam, Canada’s Chief medical health officer, Tuesday.
“The public health agency is linking with the manufacturer to look at supplies. Quite frankly, supply is very limited globally from this company. I think the company will begin to accelerate its capacity, but the supply is not plentiful.”
While that approval has been issued, Canada will also continue to receive data from ongoing clinical trials of the drug, including two in the country. Tam warned that the drug might not be suitable for all serious COVID-19 patients, as COVID-19 can involve other organs such as the liver that seem to be affected by the drug as well.
She warned that given the side effects and the unknown nature of the new drug, it’s best only used supervision.
“You have to be in a hospital setting where somebody can monitor that,” she said. This drug should be used under close monitoring.”