OTTAWA (NEWS 1130) – Health Canada has approved, with conditions, the drug remdesivir to treat some COVID-19 patients.
Remdesivir, sold under the brand Veklury, is used to treat those with pneumonia who need extra oxygen to breathe.
It’s the first drug the national health agency has greenlit to treat the coronavirus. The approval comes after an expedited six-week review of the medication, which is already being used in some countries like the U.S., Japan, and Australia.
“This expedited review was made possible in part through international regulatory cooperation with comparable regulators,” Health Canada says. It’s approved for use in adults as well as young people “aged 12 years and older with a body weight of at least 40 kg.”
JUST IN: Health Canada has approved, with conditions, drug remdesivir to treat COVID-19 patients w/severe symptoms. Drug helps those who have pneumonia & need extra oxygen to breathe. Approval comes after 6-week review of the medication, which is already in use in some countries.
— NEWS 1130 (@NEWS1130) July 28, 2020
The drug will only be used in facilities where the patient is being closely monitored, Health Canada says, adding all effects will be documented and submitted to the authority by the manufacturer of Veklury, Gilead Sciences Canada.
The drug’s safety, efficiency in treatment, as well as data from clinical trials, and other data will be monitored and documented.
Health Canada says it will closely monitor the use of remdesivir, and that it will take quick action if there are any concerns, noting “a small number of patients have been or are being treated with remdesivir in Canada under the Special Access Program.”
If fully approved, the Special Access Program won’t be required for use of the drug. There are currently two clinical trials to test remdesivir.