Health Canada grants emergency-use authorization to Eli Lilly's COVID-19 antibody treatment
TORONTO -- Health Canada has authorized Eli Lilly and Co's monoclonal antibody therapy for emergency use in helping treat COVID-19 infections.
According to a press release issued Friday, the single antibody treatment called bamlanivimab has been approved for use in adults and children aged 12 or older with mild to moderate coronavirus infections.
Lilly says the treatment is for those who risk progressing to severe COVID-19 symptoms or hospitalization. It is not authorized for patients who are already hospitalized or require oxygen.
"This authorization in Canada furthers our goal of making bamlanivimab available to patients who need it around the world and is evidence of the strong collaboration between industry and governments to get COVID-19 medicines to people as quickly as possible," Lilly chairman and CEO David A. Ricks said in the release.
Ricks added that the treatment will be available in Canada "soon."
Lilly anticipates manufacturing up to one million doses of bamlanivimab by the end of 2020 for use around the world through early next year, according to the release.
Bamlanivimab is the first monoclonal antibody to be authorized for use in treating coronavirus and was granted emergency-use by the Food and Drug Administration in the U.S. at the beginning of November.
The treatment is a recombinant, neutralizing human IgG1 monoclonal antibody that is directed against the spike protein of SARS-CoV-2, the virus that causes COVID-19. According to the release, bamlanivimab is designed to block viral attachment and entry into human cells, thus neutralizing the virus and potentially treating COVID-19.
The antibody therapy, which must be infused in a hospital or other health-care setting, was developed in partnership with the Canadian biotech company AbCellera.
"As a Canadian company, we are proud to contribute to the global fight against COVID-19 and hope our efforts will help people in Canada and around the world in the face of this medical emergency," AbCellera CEO Carl Hansen said in the release.
"We applaud Lilly for bringing bamlanivimab to patients at record speed and its commitment to ensure treatment access for patients with high unmet needs, no matter where they live."
Lilly scientists developed the antibody in less than three months after it was discovered by AbCellera in a blood sample taken from one of the first U.S. patients who recovered from the virus.
Authorization by Health Canada was based on a Phase 1 study published in the New England Journal of Medicine in October. The study found that the treatment seemed to lower the risk of hospitalization and ease some symptoms in a small number of patients with mild to moderate cases of COVID-19.
The company says a Phase 2 trial of bamlanivimab in COVID-19 patients in the ambulatory setting and a Phase 3 study looking at the prevention of COVID-19 in residents and staff at long-term care facilities is ongoing.
Health Canada granted authorization for Lilly’s antibody therapy under Section 3 of the federal government's Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
There are no Canadian patients or physicians currently using the antibody treatment, according to Lilly.