Notice: Prescription Drug List (PDL): Sotrovimab (COVID-19)

Date: August 5, 2021
Our file number: 21-114312-127

The purpose of this Notice of Amendment is to notify about the addition of sotrovimab to the Prescription Drug List (PDL) for human and veterinary use.

The new medicinal ingredient will be added to the PDL as the following:

This addition is effective at the time of posting.

Rationale

A scientific review of this drug against the criteria set out in C.01.040.3 of the Food and Drug Regulations indicates that this medicinal ingredient requires prescription status.

Sotrovimab is indicated for the treatment of mild to moderate coronavirus disease 2019 (COVID-19), confirmed by direct SARS-CoV-2 viral testing, in adults and adolescents (12 years of age and older weighing at least 40 kg) who are at high risk for progressing to hospitalization and/or death.

Sotrovimab is not authorized for use in patients:

• who are hospitalized due to COVID-19, OR
• who require oxygen therapy due to COVID-19, OR
• who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity).

Treatment with sotrovimab has not been shown to benefit patients hospitalized due to COVID-19. SARS CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Should you have any questions on these amendments to the Prescription Drug List please contact:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9
Email: hc.drug.prescription.status-statut.dordonnance.des.drogues.sc@canada.ca