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.
Clover Bio announces SCB-1019 vaccine candidate Phase I trial data in initial young adult cohort
Sanofi launches Verorab for rabies prophylaxis in UK
BioVaxys expands patent portfolio for DPX delivery platform and advances DPX SurMAGE
VGXI names new chief accounting officer
Moderna reports positive interim results from next-generation COVID-19 vaccine trial
Valneva launches Phase 1 trial for next-generation Zika vaccine
Circio Holding ASA confirms licensing deal with IOVaxis Therapeutics in China and Singapore
Everest Medicines names new chief medical officer and chief product officer
Pfizer's PREVENAR 20 gains European Commission approval for paediatric pneumococcal vaccine
Virbac expands presence in Japan with Sasaeah acquisition
Pfizer reveals strong efficacy data for ABRYSVO in older adults against RSV