CATIE News

6 August 2020 

Remdesivir (Veklury)—the first drug approved in Canada for COVID-19 treatment

  • Health Canada has approved an antiviral drug to treat severe cases of COVID-19
  • Remdesivir can only be given intravenously and only under clinical monitoring
  • This is the first drug approved in Canada to treat the novel coronavirus disease

After an extensive evaluation, Health Canada has approved the antiviral drug remdesivir (to be sold under the brand name Veklury) for use in people who have all three of the following:

  • severe symptoms of coronavirus disease 2019 (COVID-19)
  • pneumonia
  • require extra oxygen to help them breathe

Health Canada has authorized the use of remdesivir in the following populations:

  • adults
  • adolescents (aged 12 and older with a body weight of at least 40 kilograms)

Health Canada has stated the following:

  • Remdesivir is to be “administered intravenously and will be used only in healthcare facilities where patients can be closely monitored.”
  • Health Canada “will continue to closely monitor the safety of remdesivir in Canada and will take prompt action should any safety concerns arise.”

Health Canada’s approval of remdesivir is conditional. The drug’s developer, Gilead Sciences, will continue to supply reports on the safety and effectiveness of remdesivir, including data from people with pre-existing liver and kidney disease.

Access

Until now, access to remdesivir has occurred through Health Canada’s Special Access Program (SAP). However, Gilead is working with the Public Health Agency of Canada (PHAC) to make a limited supply of remdesivir available in Canada. Gilead has stated that PHAC will liaise with Canada’s provinces and territories to “ensure a fair and equitable allocation [of remdesivir] within Canada.”

Gilead will continue to review requests for compassionate access to remdesivir “for the emergency treatment of pregnant women and children with confirmed COVID-19 and severe manifestations of disease.”

According to Gilead, the recommended dosage of remdesivir in patients who are 12 years of age and older and who weigh at least 40 kilograms is as follows:

  • Day 1 – single loading dose of remdesivir 200 mg given by intravenous infusion
  • Day 2 onwards – 100 mg remdesivir given once daily by intravenous infusion

The total duration of treatment should be at least five days and not more than 10 days.

The approximate five-day cost of remdesivir is CAN $3,122. Hopefully, this drug will be subsidized by Canada’s provinces and territories, and insurance companies.

                                                                                                                                                                —Sean R. Hosein

RESOURCES:

Remdesivir—background and safetyTreatmentUpdate 237

Preliminary results from a placebo-controlled study of remdesivirTreatmentUpdate 237

Remdesivir moves forwardTreatmentUpdate 237

Information on some experimental treatments for COVID-19TreatmentUpdate 237

 

REFERENCES:

  1. Health Canada. Remdesivir authorized with conditions for the treatment of patients in Canada with severe COVID-19 symptoms. Press release. 28 July 2020.
  1. Gilead Sciences. Remdesivir for injection. Product monograph. 27 July 2020.
  1. Kolata G. Remdesivir, the first coronavirus drug, gets a price tag. The New York Times. 29 June 2020. Available at: https://www.nytimes.com/2020/06/29/health/coronavirus-remdesivir-gilead.html?searchResultPosition=2 [subscription may be required].
  1. Kapczynski A, Biddinger P, Walensky R. Remdesivir could be in short supply. Here’s a fix. The New York Times. 28 July 2020. https://www.nytimes.com/2020/07/28/opinion/remdesivir-shortage-coronavirus.html?searchResultPosition=1 [subscription may be required].