Canadians infected with the coronavirus will soon have access to an antibody treatment similar to one given to U.S. President Donald Trump, with Ottawa unveiling a US$32.5-million deal to buy thousands of doses of the drug.
Public Services and Procurement Minister Anita Anand announced Tuesday that the federal government has agreed to buy as many as 26,000 doses of bamlanivimab, an Eli Lilly drug developed in partnership with the Vancouver company AbCellera Biologics.
The drug is the first treatment to receive an interim green light from Health Canada under a new approval mechanism designed to allow treatments and vaccines for COVID-19 into the country more swiftly.
Health Canada granted the medication interim authorization on Friday.
The approval and purchase of bamlanivimab comes at a moment when Canada is desperate for better treatments for COVID-19, the disease caused by the coronavirus. Infections, hospital admissions and deaths are surging in every province west of the Maritimes, prompting provincial governments to impose new restrictions, including lockdowns, to curb spread of the virus.
Bamlanivimab could help, but it’s no silver bullet, experts say.
“We all want to mitigate infections that happen in patients,” said Srinivas Murthy, a critical care and infectious diseases doctor at BC Children’s Hospital who leads the Canadian arm of a major World Health Organization trial on COVID-19 treatments. “But we don’t know if this is the drug to do that. If it is, how do you best roll it out in the Canadian health care system?”
Bamlanivimab is a lab-created monoclonal antibody designed to stop or slow down SARS-CoV-2, the virus that causes COVID-19, from replicating inside the body. It has to be given as soon as possible after a person is infected to work well. The rub is that most people made seriously ill by COVID-19 don’t experience severe symptoms until later in the course of their illness, when the immune system goes into overdrive to fight off the virus.
By then, it’s too late for Eli Lilly’s antibody to help. A U.S. government-sponsored trial of the drug in hospitalized COVID-19 patients was halted because it didn’t seem to improve the condition of that group of patients.
Regeneron Pharmaceuticals, the company that makes a related antibody cocktail given to Mr. Trump after he was infected in October, recently stopped enrolling very sick hospitalized patients in its trial for the same reason. On Saturday, the U.S. Food and Drug Administration approved Regeneron’s product for emergency use in COVID-19 patients who are high-risk of serious illness but not yet admitted to hospital.
Former New Jersey governor Chris Christie, who was infected around the same time as the outgoing president, received Eli Lilly’s antibody drug.
Timing wouldn’t be as much of an impediment if bamlanivimab were a pill. But it’s given as an hour-long, supervised intravenous infusion at a cost to the Canadian government of US$1,250 for the medication alone. In Canada, IV drugs are most commonly delivered in hospitals, although private clinics sponsored by drug companies and some home-care services offer them as well.
“We don’t really have the capacity in the health care system to go out [to people’s homes] and give IVs and give monitored drugs that have just been approved,” Dr. Murthy said.
Still, if the right, high-risk patients can be identified and offered treatment early enough after a positive test, there is hope that bamlanivimab and other monoclonal antibodies could reduce the number of COVID-19 patients admitted to hospital.
The interim results of a Phase 2 trial, published in the New England Journal of Medicine, found that when given early to outpatients, bamlanivimab reduced viral load and led to fewer hospital admissions, although the number of seriously ill patients in both the placebo and drug arms of the trial turned out to be small.
“With this pandemic surge, there is a need for a therapeutic bridge to much-needed vaccines,” said Doron Sagman, vice-president of research and development and medical affairs for Eli Lilly Canada. Bamlanivimab could help to keep high-risk patients from becoming sick enough to require hospital care until vaccines for COVID-19 are widely available in Canada, he said.
Health Canada’s instructions for bamlanivimab define “high-risk” primarily as COVID-19 patients who are over the age of 65 or have obesity, chronic kidney disease, diabetes or diseases that suppress the immune system. They also say the drug should be administered as soon as possible after a positive test or no more than 10 days after symptoms begin.
Eli Lilly developed the drug in partnership with AbCellera, a Vancouver biotech company that used artificial intelligence to analyze the blood of recovered COVID-19 patients to pinpoint the best antibodies to copy and turn into drugs to fight the viral infection.
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