World News – CA – Health Canada Grants Emergency Authorization to Eli Lilly’s COVID-19 Antibody Treatment

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This photo by Eli Lilly shows the drug bamlanivimab. It is the first antibody drug to help the immune system fight COVID-19. (Courtesy Eli Lilly via AP)

TORONTO –
Health Canada has approved Eli Lilly and Co’s emergency monoclonal antibody therapy for the treatment of COVID-19 infections.

The single antibody treatment bamlanivimab has been approved for use in adults and children aged 12 and over with mild to moderate coronavirus infections, according to a press release released on Friday.

Lilly said the treatment is intended for those at risk of developing severe COVID-19 symptoms or going to the hospital. It is not approved for use in patients who are already in the hospital or in need of oxygen.

« This approval in Canada supports our goal of bringing bamlanivimab to patients who need it around the world and is evidence of the close collaboration between industry and governments to deliver COVID-19 drugs to people as quickly as possible, » said David, Chairman and CEO of Lilly EIN. Said Ricks in the press release.

Lilly expects to manufacture up to one million doses of bamlanivimab by the end of 2020 for global use by early next year.

Bamlanivimab is the first monoclonal antibody approved for the treatment of coronavirus and has been approved for emergency use by the Food and Drug Administration in the United States. S.. . 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 publication, bamlanivimab is said to block virus attachment and entry into human cells, thereby neutralizing the virus and potentially treating COVID-19.

Antibody therapy, which must be infused in a hospital or other healthcare facility, was developed in collaboration with the Canadian biotech company AbCellera.

« As a Canadian company, we are proud to be part of the global fight against COVID-19 and hope our efforts will help the people of Canada and around the world in the face of this medical emergency, » said Carl Hansen, CEO of AbCellera, in the press release.

« We applaud Lilly for delivering bamlanivimab to patients at record speed and for making a commitment to providing access to treatment for patients with high unmet needs, regardless of where they live. « 

Lilly scientists developed the antibody in less than three months after AbCellera found it in a blood sample taken from one of the first U.. S.. . Patients who have recovered from the virus.

Health Canada approval was based on a phase 1 study published in the New England Journal of Medicine in October. The study found that the treatment appeared to reduce the risk of hospitalization and relieve some symptoms in a small number of patients with mild to moderate cases of COVID-19.

The company says it is currently conducting a Phase 2 study of bamlanivimab in COVID-19 patients in the outpatient setting and a Phase 3 study to prevent COVID-19 in residents and employees of long-term care facilities.

Health Canada approved Lilly’s antibody therapy under Section 3 of the federal government’s injunction on the import, sale, and promotion of drugs for use related to COVID-19.

Full coverage at CTVNews. ca / coronavirus

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Eli Lilly and Company, Health Canada, Antibodies