FDA Grants Emergency Use Authorization to Bamlanivimab for COVID-19

The FDA has granted emergency use authorization to bamlanivimab, an antibody treatment for COVID-19.

“It’s a great day for science and medicine,” said Daniel Skovronsky, MD, PhD, Chief Scientific Officer of Eli Lilly, which manufactures the treatment. The company and its collaborators, including the NIH, were able “to create a new drug, manufacture it, test it in clinical trials, and get it authorized for use in just 7 months,” he said.

In October, Eli Lilly reached a $375 million deal to sell 300,000 doses of bamlanivimab to the U.S. federal government. Under this agreement, the treatment will be available at no cost to patients, but health care providers will be able to charge for its administration. By the end of 2020, the company told The New York Times, it expects to manufacture enough doses to treat up to one million people – not enough to curb a virus infecting more than 110,000 people every day in the U.S.

“It’s kind of the best times for these therapies to enter, because they can have an impact,” said Walid Gellad, MD, MPH, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “It’s also the worst time because we don’t have enough doses, and it’s going to add to the backlog of testing.”

Eli Lilly will begin shipping the antibody treatment to AmerisourceBergen to distribute it with help from the U.S. government and state health departments. The treatment will be distributed based on the number of confirmed COVID-19 cases in each state or territory for the prior week.

The FDA’s decision was announced on the same day that Pfizer released early results from its coronavirus vaccine trial. Pfizer’s vaccine could be granted emergency authorization sometime this year but would not be available to Americans until 2021.

Source: The New York Times, November 9, 2020.