Health Canada has approved the first drug in the country to treat severe COVID-19 symptoms.
They gave remdesivir (brand name Veklury) the green light, but there are conditions tied to the approval.
It can only be used in people who are 12 and older with a body weight of at least 40 kg.
Remdesivir is administred intravenously and can only be used in healthcare facilities where patients can be closely monitored.
The manufacturer of the drug, Gilead Sciences Canada, Inc., will also have to submit to Health Canada the following:
- post-market safety monitoring reports, as well as reports on all serious adverse drug reactions, annual pregnancy safety reports and any foreign regulatory actions related to the safety of remdesivir;
- any further data on the safety and efficacy of the drug, including final data from ongoing clinical trials and additional safety data on patients with liver and kidney disease; and
- further quality data confirming that the manufacturing processes and controls will consistently produce product of suitable quality for the intended use.
The drug has been granted emergency or conditional authorization in other countries including the U.S. Europe, Japan, Singapore and Australia.
For more information, click here.