Health Canada approves first drug for treatment of COVID-19

Originally used to treat Ebola, the antiviral medicine remdesivir is Canada's first-approved treatment for COVID-19, says Health Canada.

Manufactured by Gilead Sciences Canada, remdesivir (Veklury) is administered intravenously and has been granted authorisation for treatment of patients with severe symptoms of COVID-19 who have pneumonia and require extra oxygen to help them breathe. Specifically, remdesivir is approved for use in adult and adolescent patients aged ≥12 years with a bodyweight of ≥40kg. However, Gilead Sciences Canada did not seek approval to use remdesivir to treat younger children or pregnant women.

Health Canada said that it completed an expedited 6-week review "of the available safety, efficacy and quality data to determine that the drug's benefits outweigh its risks when used for the authorized indication. This expedited review was made possible in part through international regulatory cooperation with comparable regulators".

Of note, this approval of remdesivir was made with certain conditions, including:

• that the drug will be used only in healthcare facilities where patients can be closely monitored;

• that Gilead Sciences Canada will submit postmarketing safety monitoring reports to Health Canada − including all reports of serious ADRs, annual pregnancy safety reports, and any foreign regulatory actions related to the safety of remdesivir;

• that Gilead Sciences Canada will also submit to Health Canada any further data on the efficacy and safety of remdesivir − including final data from ongoing clinical trials, and additional safety data on patients with liver and kidney disease; and

• submit further quality data to Health Canada confirming that the manufacturing processes and controls will consistently produce product of suitable quality for the intended use.

Furthermore, remdesivir has also been granted emergency or conditional authorisation for this indication in the US, Europe, Japan, Singapore and Australia. Health Canada said it will continue to closely monitor the safety of remdesivir and will take action should any safety concerns arise. There are two ongoing clinical trials approved by Health Canada, which will provide further data on the efficacy and safety of remdesivir. There is currently no expiry on the remdesivir's approval.