Health Canada Approves Remdesivir For Treatment of COVID-19

Health Canada has approved Remdesivir with conditions for the treatment of COVID-19 and this is the first drug authorized in Canada for COVID-19 treatment.

The drug Remdesivir (brand name Veklury) manufactured by Gilead Sciences Canada, Inc. is authorized for the treatment of patients with severe symptoms of COVID-19 who have pneumonia and require extra oxygen to help them breathe.

 

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS.

Health Canada has approved this drug with conditions after an expedited six-week review of the available safety, efficacy and quality data and mandates that the manufacturer will ensure the continued safety, efficacy and quality of the drug.

As per the news release, Remdesivir is authorized for use in adults and adolescents (aged 12 years and older with a body weight of at least 40 kg). Remdesivir is administered intravenously and will be used only in healthcare facilities where patients can be closely monitored.

Remdesivir has also been granted emergency or conditional authorization in the U.S., Europe, Japan, Singapore and Australia. There is no preset expiry date on the authorization.

Remdesivir was allowed to treat a limited number of COVID-19 patients in Canada under the Special Access Program. Since the authorization, the Special Access Program will no longer be required to access the drug.

Currently, there are two ongoing clinical trials in Canada to evaluate the safety and effectiveness of Remdesivir. These clinical trials will continue to gather more data on the drug.

 
   

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