Eli Lilly Covid-19 antibody drug granted FDA emergency clearance

A drug that has been shown to help prevent hospitalizations in high-risk patients already suffering from Covid-19 will soon be widely available, thanks to an FDA emergency clearance issued Monday evening for an antibody therapy manufactured by Eli Lilly & Co. .

The drug, called bamlanivimab, is a single antibody treatment that must be administered by healthcare professionals in a hospital or healthcare facility. In a declaration, the FDA said the drug was “specifically directed against the SARS-CoV-2 spike protein, which is designed to block attachment of the virus and entry into human cells.”

“The FDA’s emergency clearance for bamlanivimab provides healthcare workers at the forefront of this pandemic with another potential tool in treating patients with Covid-19,” said Dr Patrizia Cavazzoni, interim director of the Center for Drug. FDA Evaluation and Research. . “We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available.”

In October, the New England Journal of Medicine published the results of a double-blind placebo-controlled clinical study conducted with a small number of patients with mild to moderate symptoms of Covid-19, which found that treatment measurably reduced the risk of hospitalization and alleviated some symptoms .

The Eli Lilly drug offers doctors the opportunity to start fighting the virus before its progression becomes advanced in high-risk patients. The treatment will serve as a compliment to other remedies that have already received the green light from the FDA, such as the remdesivir antiviral cocktail from Gilead Sciences Inc., intended for patients who are already seriously ill with Covi-19.

The company said the treatment would be provided to patients at no cost and that it was ready to have 100,000 doses of the drug ready for shipping in days and would produce one million doses by the end of 2020.