On Lilly's request to the FDA to revoke the Emergency Use Authorization of bamlanivimab alone in the U.S., and what it means for Canada

On April 16, Eli Lilly and Company issued a press release announcing that we had requested that the FDA revoke its Emergency Use Authorization of bamlanivimab alone as a treatment for COVID-19. This action is being taken to expedite the transition from bamlanivimab alone to bamlanivimab plus etesevimab together for the treatment of COVID-19 in the US. This request is not due to any new safety concerns.

It’s important to note that this announcement is specific to the United States as a result of the specific mix of variants of concern that are in circulation in that country.

In Canada, the situation is quite different. According to the Government of Canada’s COVID-19 Epidemiology update, more than 95% of overall Canadian cases caused by variants are caused by the UK variant (B.1.1.7 variant), which is effectively neutralized by bamlanivimab used alone.

Lilly is not requesting the withdrawal of authorizations for bamlanivimab alone in any other jurisdiction at this time. Bamlanivimab alone is authorized for use as a treatment for high-risk patients with mild to moderate COVID-19 in Canada. Currently bamlanivimab and etesevimab together are not authorized for use in Canada, but we have shared this data and are actively working with Health Canada to enable their full review of this therapeutic combination. As with bamlanivimab used alone, this combination effectively neutralizes the UK variant.

From Lilly’s perspective, this current wave of the pandemic is all the more reason to use the bamlanivimab we have in Canada. Given that the UK variant is still the dominant variant in Canada, empiric treatment with monoclonal antibody therapies may be clinically beneficial.

As health authorities work with commendable speed to reduce the rate of infections by vaccinating as many people as possible, they are also increasingly rationing supplies—rationing care—as ICUs are stretched to capacity.

What’s missing from Canada’s approach to managing this pandemic is a strategy for reducing the numbers of people who progress from infection to hospitalization, and who progress from primary care to the ICU.

Other countries are making significant investments and actively working to increase the availability of treatments for COVID-19, with good success.

Here in Canada, we want to help. We published a playbook on the effective use of bamlanivimab. We’re working to compile, analyze and summarize the international experience in effectively using this medicine, and to make that information available to Canadian health agencies. We’ve seen success in other countries with the use of infusion centers, including mobile infusion clinics, and even with the repurposing of dialysis clinics as places to infuse this medicine. We’re eager to work with health authorities to find solutions that work for Canada.

We understand that these agencies’ capacity to take on new projects is scarce. For 14 months, this pandemic has overworked health care agencies, and we sympathize. We also sympathize with the people who contact us daily looking for bamlanivimab. We work at a pharmaceutical company because we want to help people who get sick.

People like John Tavel. Despite living carefully, John contracted the virus and, since he’s 80, he was at high risk of seeing his disease progress. His disease did progress—in fact he was hospitalized twice. His daughter Robyn, who lives in the United States, said “I was seeing great success and experience with antibody treatments that were keeping patients out of hospital and accelerating recovery times,” so the family contacted us.

Robyn asked, “why isn't the healthcare system using these treatments if we have them here in Canada to use? If it’s the cost—my dad had to go to the hospital on two separate occasions to receive support and ineffective treatments. Clearly that’s more expensive, and it feels as if we’re not using all the tools that we have available to us.”

The pharmaceutical industry is in a position to help. We discover new medical tools, rigorously test them in clinical trials and gather international experience with their successful use. We’re eager to collaborate with Canada’s health authorities to help keep people out of the hospital.