Published Friday, April 23, 2021 4:18PM EDT
Last Updated Friday, April 23, 2021 10:40PM EDT
“It's actually very frustrating that we have a therapy available to us that we're not actually able to use,” said infectious disease expert Dr. Deepali Kuma.
Bamlanivimab is a monoclonal antibody directed against the spike protein of SARS-CoV-2, the virus that causes COVID-19. The drug mimics the immune system's ability to fight off the virus and was developed by AbCellera Biologics Inc. in Vancouver with the support of the federal government, which had committed up to $175.6 million to the company in May 2020 to develop antibody therapies.
According to Health Canada, bamlanivimab may prevent symptoms from becoming worse and reduce hospitalizations in high-risk patients who are infected with COVID-19.
The one-dose treatment, which is sold by Eli Lilly Canada, Inc., can be used in health-care facilities such as hospitals, as it is given by infusion into the veins of patients.
As an antibody therapy, it is part of a major class of drugs normally used to treat diseases like cancer and rheumatoid arthritis, Sachdev Sidhu, a professor of molecular genetics at the University of Toronto, said in an interview.
“So as a method of treatment it is a … validated form, so this is not some off-the-cuff methodology,” said Sidhu, who specializes in antibody engineering.
Health Canada authorized the drug in November 2020 under the interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19.
According to Health Canada, 26,000 doses of the treatment were purchased for $40 million and distributed amongst the provinces.
However, almost none of those doses have been used.
Countries around the world have been using bamlanivimab to help keep COVID-19 patients out of hospital and reduce deaths for months. More than 400,000 COVID-19 patients worldwide have benefited from the drug, according to Michael McDougall, a spokesperson for Eli Lilly.
There are currently four other types of antibody drugs made by different companies, waiting for approval by Health Canada. The agency told CTVNews.ca that it was expediting these reviews, but could not give a more precise timeline on when a decision might be made.
According to AbCellera Biologics, studies have shown the treatment is effective against SARS-CoV-2, and the variant first identified in the United Kingdom.
Despite this, provincial health authorities have not yet made the treatment available to Canadians.
AbCellera Biologics CEO Carl Hansen told CTV National News it is “heartbreaking” that the drug is not accessible in Canada.
“We are proud to have contributed to a solution that's helping so many people around the world, but of course, it would be that much better if this was actually getting to people in our own communities, and was here to protect the ones that we love,” Hansen explained.
Hansen said that provincial government did not issue a plan on how to administer the treatment, causing doctors to leave it on shelves.
“To think that we've invented a therapy here and having taken the steps to bring it to patients is a failure of the system and one I think that needs to be corrected, as soon as possible,” Hansen said.
CTV News has reached out to provincial health units for comment, but did not hear back before this story was published.
To have a Canadian company get federal funding to develop the drug, see the drug approved, but then have it “sitting in the freezer -- that’s a mystery,” Sidhu said. “Canada is dropping the ball.”
Meanwhile, the U.S. Food and Drug Administration's recent revocation of bamlanivimab's Emergency Use authorization could cause some confusion with the public. A Health Canada spokesperson told CTVNews.ca via email that it was aware of the status change and noted that it was at the request of Eli Lilly, "given evidence that it is ineffective when used alone against certain COVID-19 variants of concern circulating in the U.S. and the availability of alternative therapies in the U.S. This action was not prompted by a safety concern."
"There is no change to bamlanivimab authorization in Canada and Eli Lilly has not requested that Health Canada revoke its authorization. Bamlanivimab used by itself is effective against the B.1.1.7 (UK) variant, which is the main variant circulating in Canada at this time," said Health Canada's Geoffroy Legault-Thivierge.