Question Period Note: ACCESS TO TREATMENTS FOR COVID-19

• The COVID-19 pandemic has created unprecedented challenges to Canada’s medical system, and there is a need for treatments to support the response.

KEY MESSAGES
• Health Canada is expediting the review of all treatments for COVID-19 while continuing to ensure that these products meet standards for safety, efficacy and quality.
• Health Canada has authorized 4 drugs to treat COVID-19, including remdesivir for hospitalized people and 3 biologic treatments for non-hospitalized people who have mild or moderate COVID symptoms and are at risk of developing severe disease. Several other treatments, including oral antivirals, are under review to help prevent or treat COVID.
• The Government of Canada has procured many of these treatments and continues to engage proactively with domestic and international companies to negotiate advance purchase agreements for the procurement of treatments to ensure timely access.
IF PRESSED ON OMICRON
• Health Canada is working with manufacturers and international regulatory partners, including WHO, to assess the potential impact of the omicron variant on approved test kits, vaccines and treatments.
• As evidence emerges, Health Canada will take action and inform Canadians if there are changes to the safety or effectiveness of COVID-19 health products in Canada because of the omicron variant.
• If new vaccines or treatments are needed to address the omicron variant, Health Canada will prioritize the reviews to make these products available as soon as possible while maintaining high standards for safety, efficacy and quality.
IF PRESSED ON MOLNUPIRAVIR
• Molnupiravir is an oral antiviral treatment that shows promise in treating non-hospitalized COVID-19 patients with mild to moderate COVID-19 and at high risk for progression to severe disease.
• Since August 13, 2021, Health Canada has been working with Merck and international regulatory partners to expedite review of the drug submission.
• Health Canada is aware that the efficacy of molnupiravir is lower than previously reported. Because this is a rolling submission, Merck will continue to submit evidence to Health Canada to support the product’s safety, efficacy and quality and Health Canada will conduct a full review of all the evidence prior to making a decision.
IF PRESSED ON PF-07321332 (PAXLOVID) (Pfizer)
• On December 1, 2021, Pfizer filed a new drug submission for the antiviral drug PF-07321332, which has the proposed brand name Paxlovid. This drug would be used, in combination with the HC-approved antiviral ritonavir, as an oral treatment for non-hospitalized patients with COVID-19 and at high risk of progressing to severe disease.
• As with all COVID-19 submissions, Health Canada will expedite the review of this drug and work with international regulators to ensure Canadians have access to this oral treatment should it meet the Department’s stringent requirements for safety, efficacy and quality.
IF PRESSED ON IVERMECTIN
• There is no evidence that ivermectin works to prevent or treat COVID-19, and it is not authorized for this use. To date, Health Canada has not received any drug submission or applications for clinical trials for ivermectin for the prevention or treatment of COVID-19.
• A veterinary version of this medication is available to treat parasitic infections in animals. People should not use the veterinary version of this product to treat or prevent COVID-19 or for any other reason. Canadians should never consume health products intended for animals because of the potential serious health dangers posed by them.
IF PRESSED ON BAMLANIVIMAB
• Health Canada is aware that US FDA has revoked the Emergency Use Authorization for bamlanivimab, at the request of Eli Lilly
• This revocation is related to lack of efficacy against emerging variants of concern circulating in the US, in particular the Californian variants.
• There are no safety concerns with bamlanivimab. This decision was made in the context of the US having other treatments available, which work better against some of the emerging variants.
• Health Canada has updated the product labelling for bamlanivimab and communicated to healthcare professionals to provide information on variants and their impact on bamlanivimab efficacy, and has also discussed this issue with the provinces and territories.
• While bamlanivimab may continue to be used in Canada at this time, Health Canada has now also authorized several other biologic treatments that are effective against circulating variants.
IF PRESSED ON INTERIM ORDER/AMENDED REGULATIONS
• Health Canada put in place temporary Interim Orders to facilitate expedited access to COVID-19 drugs and vaccines.
• Regulatory changes were made on March 18, 2021 to permanently transition measures from the Interim Order to the Food and Drug Regulations, to ensure that vaccines and drugs authorized under the Interim Order can continue to be sold and that new COVID-19 products can be reviewed and authorized using similar flexibilities.
• Companies that had a vaccine or drug authorized under the Interim Order were required to make a submission to Health Canada to receive authorization under the Food and Drug Regulations.
• To-date, the vaccines from Pfizer-BioNTech and Moderna have been authorized under the new Regulations. The vaccines from AstraZeneca and Janssen remain under review, but their Interim Order authorizations remain valid until Health Canada has completed the reviews.
• Vaccines not yet authorized for sale in Canada, such as those from Novavax and Medicago, are also being reviewed under the new Regulations.
• A number of treatments not yet authorized for sale in Canada, such as oral antivirals and monoclonal antibodies, are also being reviewed under the new Regulations.
IF PRESSED ON INTERNATIONAL COLLABORATION
• Health Canada is leveraging its strong international partnerships with the US Food and Drug Administration, the European Medicines Agency, and the World Health Organization, amongst others, to share information and to raise our collective level of awareness of evidence-based approaches for treatments. The objective is to work towards alignment on regulatory requirements and to stay informed of any potential treatments.

Stakeholder Engagement

Information about health products for COVID-19 has been consolidated into a website for the health product industry, so they know how to apply for regulatory approval and who to contact for questions. Information relevant to health professionals and Canadians is provided on the COVID-19 website.

Health Canada is actively engaging with stakeholders in the health product industry to proactively identify, track and provide support to sponsors of clinical trials and treatments related to COVID-19.

TREATMENTS

Dexamethasone
Although not specifically authorized for the treatment of COVID-19, clinical trial results announced in June 2020, showed that dexamethasone, used since the 1960s to reduce inflammation, cut death rates by around a third among the most severely ill COVID-19 patients admitted to hospital. As a result, the WHO has updated its guidelines on treating people with COVID-19.

COVID-19 Authorized Treatments

Remdesivir
On 27 July 2020, Health Canada authorized the drug remdesivir (brand name Veklury) for the treatment of patients (12 years of age or older, who weigh at least 40 kg) with severe symptoms of COVID-19 who have pneumonia and require extra oxygen to help them breathe. Health Canada approved this drug with conditions for the manufacturer to ensure its continued safety, efficacy and quality. Despite the World Health Organization’s (WHO) updated guidelines advising against the use of remdesivir, Health Canada continues to support this drug as a treatment option, which is in line with other international regulators. Specifically, remdesivir modestly decreases patient time in hospital and continues to provide benefit for patients and health care systems when used according to the authorized indication. Health Canada will continue to evaluate information about remdesivir as additional information about its use continues to be collected, and will take the appropriate steps to ensure the health and safety of Canadians.

Bamlanivimab
On November 20, 2020, Health Canada authorized the Eli Lilly drug bamlanivimab, a monoclonal antibody. Bamlanivimab was authorized under the Interim Order and is currently under review under the amended Food and Drug Regulations. The updated clinical information is included in the submission under review and will inform the regulatory decision later in Fall 2021.

Casirivimab and imdevimab combination
Casirivimab and imdevimab are monoclonal antibodies that are administered together by intravenous infusion as a single dose, and this product has shown a clear benefit for patients with mild to moderate COVID-19 who are at high risk of hospitalization and/or death. This combination drug treatment was developed by U.S. company Regeneron Pharmaceuticals Inc. and is distributed in Canada by Hoffmann-La Roche Ltd.

Sotrovimab
On July 30, 2021, Health Canada authorized Sotrovimab from GlaxoSmithKline. This monoclonal antibody is approved for the treatment of mild to moderate COVID-19 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.

COVID-19 Treatment Submissions Under Review

Favipiravir is a broad-spectrum antiviral drug that has not been authorized in Canada. On December 18, 2020, Dr. Reddy’s Laboratories filed a submission to Health Canada for the treatment of COVID-19. Health Canada is awaiting results from an ongoing clinical trial that concluded in October 2021.

Baricitinib is being investigated as a treatment that may reduce the complications related to the cytokine storm as well as potentially inhibiting cell proteins that have a role in viral replication. On May 13, Eli Lilly filed a drug submission for baricitinib with Health Canada and as of December 1, this submission is under review. Health Canada is awaiting results from an ongoing clinical trial that will conclude in February 2022.

Molnupiravir is an anti-viral, in capsule form, for the treatment of infected adults who are at risk of progressing to severe COVID-19 disease or hospitalization. On August 13, Merck filed a drug submission with Health Canada and as of October 7, this submission is under review. The United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) authorized the use of molnupiravir on November 4. The European Medicines Agency (EMA) issued advice on November 19, allowing member states to begin using the product for emergency use situations while it continues its on-going rolling review for market authorization. On November 30, the United States Food and Drug Administration’s (US FDA) Antimicrobial Drug Advisory Committee recommended the emergency use authorization for molnupiravir. The FDA will take their recommendations into consideration as it continues to review Merck’s application for emergency use authorization for molnupiravir.

PF-07321332 (proposed brand name Paxlovid) is an oral anti-viral drug being developed by Pfizer for the treatment and post-exposure prophylaxis of COVID-19 in non-hospitalized adult patients. It is administered with another drug, ritonavir, which acts as a booster to improve bioavailability. PF-07321332 is not yet authorized in any jurisdiction. Pfizer has filed applications with the MHRA and the EMA. On December 1, 2021, Pfizer filed a drug submission with Health Canada.

Health Canada has three other submissions for monoclonal antibody treatments ((AstraZeneca’s Evusheld (tixagevimab and cilgavimab), Eli Lilly’s estesevimab and bamlanivimab combination and Celltrion’s Regdanvimab)). Monoclonal antibodies are being tested both as treatment for mild/moderate COVID-19, and also as prophylaxis, to prevent infection.

COVID-19 Treatment Submissions Withdrawn

On June 7 2021, the submission to authorize colchicine as a treatment of COVID-19 was withdrawn by the manufacturer. Colchicine remains authorized in Canada for the prophylaxis and treatment of gout flares and Familial Mediterranean Fever. Although unproven at the time, Colchicine was used to treat the Former President Trump and gained a lot of media attention.

The Sanoclear (Nitric Oxide) submission was withdrawn Sept. 01, 2021, with an expectation that it will be refiled once additional clinical data is available, and the leronlimab submission was withdrawn September 16, 2021.

KEY FACTS

• Health Canada is actively engaging with stakeholders in the health product industry to proactively identify, track and provide support to sponsors of clinical trials and treatments related to COVID-19.
• Health Canada has authorized 4 drugs to treat COVID-19, including remdesivir for hospitalized people and 3 biologic treatments for non-hospitalized people who have mild or moderate COVID symptoms and are at risk of developing severe disease. Several other treatments are under review to help prevent or treat COVID.