Antibody discovery company AbCellera revealed on Friday that its human antibody bamlanivimab (LY-CoV555) in 700 mg, developed through its collaboration with Eli Lilly and Company, has received the Health Canada authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
According to the company, Bamlanivimab, which has been shown in clinical trials to reduce viral load, symptoms and hospitalizations, is authorized for the treatment of adults and paediatric patients 12 years of age or older with mild to moderate COVID-19 who weigh at least 40 kg and who are at high risk of progressing to severe COVID-19 illness and/or hospitalization.
Both the Canadian interim authorization and American EUA are based on data from the company's BLAZE-1, a randomized, double-blind placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting.
Bamlanivimab was discovered from the blood of a recovered COVID-19 patient by AbCellera, scientists at the Vaccine Research Center at National Institute of Allergy and Infectious Diseases (NIAID) and Lilly. Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19.
Brazil's health regulator clears emergency use of Sinovac and AstraZeneca COVID-19 vaccines
England opens up its COVID-19 vaccination programme to more groups
Dr. Reddy's Receives Approval to Conduct Phase 3 Clinical Trial for Sputnik V Vaccine in India
Carbon Health Launches COVID-19 Vaccination Platform to Accelerate National Rollout
Kyruus Enables Online Scheduling for COVID-19 Vaccine Visits
China's Sinopharm says COVID-19 vaccine safe for children and teenagers
Publix and the State of Florida to Bring COVID-19 Vaccinations to Three Florida Counties
OnSolve's CodeRed used across the US for the management of information related to COVID-19 vaccine
Meijer Pharmacies to administer COVID-19 vaccines in the State of Michigan
China's CanSino Biologics COVID-19 vaccine shows high antibody levels in Russian trials
Hungary's government signs deal with China's Sinopharm for COVID-19 vaccine purchase