Eli Lilly’s Covid-19 Antibody Drug Just Received Emergency FDA Clearance

Eli Lilly’s Covid-19 Antibody Drug Just Received Emergency FDA Clearance
Photo: Joe Raedle / Staff, Getty Images

A drug proven to help prevent hospitalizations in high-risk patients already sick with Covid-19 will soon become widely available, thanks to an emergency FDA clearance issued Monday night for an Eli Lilly & Co.-manufactured antibody therapy.

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

“The FDA’s emergency authorization of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating Covid-19 patients,” Dr. Patrizia Cavazzoni, acting director of the FDA’s Centre for Drug Evaluation and Research, said in the statement. “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 trial conducted with a small number of patients with mild to moderate Covid-19 symptoms, which found that the treatment measurably reduced the risk of hospitalisation and eased some symptoms.

The Eli Lilly drug provides doctors with an opportunity to begin 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 been given the FDA’s green light, such as the antiviral cocktail remdesivir from Gilead Sciences Inc., which is intended for patients who are already severely ill with Covi-19.

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