The federal government is taking steps to provide Canadians with effective therapies as part of its response to COVID-19.
Health Minister Patty Hajdu announced that the Government of Canada has signed an agreement with Eli Lilly for an initial order of up to 26,000 doses of their COVID-19 monoclonal antibody therapy Bamlanivimab.
“As the COVID-19 pandemic continues, Canadians eagerly await news of new treatments and vaccines,” Hajdu said. “To provide Canadians with faster access to COVID-19 drugs, like Eli Lilly’s new antibody treatment, Health Canada is expediting its reviews of COVID-19 drugs, while maintaining its standards for safety, efficacy and quality.”
Under the agreement, deliveries of Bamlanivimab will begin in December 2020 and be completed in February 2021. Beginning in March 2021, Canada will have the option to purchase additional allocations, based on the current medical need in Canada and the global product availability.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off viruses. Bamlanivimab is a monoclonal antibody designed to block the virus from attaching to and entering human cells, thus potentially preventing the virus from causing COVID-19 illness.
Eli Lilly co-developed this therapy with AbCellera Biologics, a Vancouver-based technology company that searches, decodes and analyzes natural immune systems to find antibodies that can be developed to prevent and treat disease. The partnership combines AbCellera’s advanced antibody therapy discovery platform with Eli Lilly’s development, manufacturing and distribution capabilities.
Health Canada received Eli Lilly’s application for authorization on October 12, 2020, under the Interim Order for COVID-19 drugs, and authorized the product on November 20, 2020. This is the first authorization for a treatment for COVID-19 under the Interim Order, a temporary mechanism used to expedite approval of drugs and vaccines for COVID-19 without compromising safety and efficacy.
The authorization is based on promising data that showed that Bamlanivimab reduced COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression. Under this conditional authorization, Eli Lilly will continue to submit data to Health Canada related to the safety and effectiveness of the drug from ongoing clinical trials and on-market use.
Photo: “To provide Canadians with faster access to COVID-19 drugs, like Eli Lilly’s new antibody treatment, Health Canada is expediting its reviews of COVID-19 drugs, while maintaining its standards for safety, efficacy and quality,” said Health Minister Patty Hajdu.