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TORONTO – Health Canada has cleared Eli Lilly and Co’s monoclonal antibody therapy for emergency use in the treatment of COVID-19 infections.
According to a press release issued Friday, treatment with a single antibody called bamlanivimab has been approved for use in adults and children 12 years of age and older with mild to moderate coronavirus infections.
Lilly says the treatment is for those who are at risk of progressing to severe COVID-19 symptoms or hospitalization. It is not authorized for patients already hospitalized or in need of oxygen.
“This authorization in Canada promotes 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 deliver COVID-19 drugs to people as quickly as possible. “Lilly President and CEO David A. Ricks said in the statement.
Ricks added that the treatment will be available in Canada “soon”.
Lilly plans to produce up to one million doses of bamlanivimab by the end of 2020 for use around the world until early next year, according to the release.
Bamlanivimab is the first monoclonal antibody to be licensed for use in the treatment of coronavirus and was granted emergency use by the U.S. Food and Drug Administration in early November.
The treatment is a recombinant neutralizing human IgG1 monoclonal antibody directed against the SARS-CoV-2 spike protein, the virus that causes COVID-19. According to the release, bamlanivimab is designed to block viral attachment and entry into human cells, thereby neutralizing the virus and potentially treating COVID-19.
Antibody therapy, which is to be infused in a hospital or other healthcare setting, was developed in collaboration with the Canadian biotech company AbCellera.
“As a Canadian company, we are proud to contribute to the global fight against COVID-19 and we hope our efforts will help people in Canada and around the world facing this medical emergency,” AbCellera CEO Carl Hansen said in the statement. .
“We applaud Lilly for bringing bamlanivimab to patients at record speed and for her commitment to ensuring 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 it was discovered by AbCellera in a blood sample taken from one of the first US patients to recover from the virus.
Health Canada’s clearance 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 alleviate some symptoms in a small number of patients with mild to moderate cases of COVID-19.
The company says there is an ongoing Phase 2 study of bamlanivimab in COVID-19 patients in an outpatient setting and a Phase 3 study examining the prevention of COVID-19 in residents and staff of long-term care facilities.
Health Canada has granted authorization for Lilly’s antibody therapy under Section 3 of the Federal Government Interim Order Respecting the Import, Sale, and Advertising of Drugs for Use in Connection with COVID-19.
There are no Canadian patients or doctors currently using antibody treatment, according to Lilly.
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