Eli Lilly's LY-CoV555 gets interim authorization as a COVID treatment in Canada

The company states: "Health Canada granted authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 for the use of bamlanivimab, or LY-CoV555, as a treatment for adults and pediatric patients 12 years of age or older with mild to moderate COVID-19 who weigh at least 40 kg and are at high risk of progressing to severe COVID-19 illness and/or hospitalization, Eli Lilly announced. This authorization, the second authorization around the world for bamlanivimab, is based on data from BLAZE-1, a randomized, double-blind placebo-controlled phase 2 study in patients with recently diagnosed, mild to moderate COVID-19. In BLAZE-1, patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization. In BLAZE-1, frequency and types of adverse events were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity. Infusion reactions and other allergic hypersensitivity events have been reported. Lilly has a robust, global supply chain in place and began large-scale manufacturing of bamlanivimab at risk earlier this year. Lilly anticipates manufacturing up to one million doses of bamlanivimab 700 mg by the end of 2020, for use around the world through early next year. On November 9th, the FDA granted Emergency Use Authorization for bamlanivimab 700 mg. In the U.S., bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older who weigh at least 40 kg with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Lilly is in discussions with global regulators to make bamlanivimab available around the world. The company is focused on areas with the highest disease burden and pursuing authorization in countries such as India, Brazil, Russia and across Europe. Global allocation will be made based on Lilly's guiding principles that aim to ensure access for patients with high unmet need, no matter where they live."