US Approves Eli Lilly Covid Monoclonal Antibody Drug Therapy

Doctors are going to need a variety of tools to battle Covid given the time it is going to take to get a majority of the world's population vaccinated. 

This may be the most effective drug yet developed for reducing Covid's impact on humans. JL

Rebecca Robbins reports in the New York Times, Image by Riccardo Antimiani:

The treatment gives doctors another option for patients with Covid-19 who are not sick enough to be hospitalized but are at high risk of becoming seriously ill. Preliminary data (suggest) the new combination therapy may be better able to fight virus variants compared with a similar treatment already in use. High-risk patients with Covid-19 who were given Eli Lilly’s combination therapy were significantly less likely to end up hospitalized than those who received a placebo. No patients who were given the combination therapy died.

The U.S. Food and Drug Administration on Tuesday granted emergency use authorization to a Covid-19 therapy that combines two monoclonal antibody drugs.

The approval of the treatment, which is manufactured by the drug maker Eli Lilly, gives doctors another option for patients with Covid-19 who are not sick enough to be hospitalized but are at high risk of becoming seriously ill. Such therapies received a publicity boost under President Donald Trump when he and several other politicians took them while sick with Covid-19, but the drugs have not been widely used in many places, even as hospitalizations soared through the fall and into the winter.

Researchers are hopeful about suggestions in preliminary data that the new combination therapy may be better able to fight virus variants compared with a similar treatment already in use.

The therapy combines the company’s drug known as bamlanivimab — which was authorized in November and is being used for high-risk Covid-19 patients — with a second drug known as etesevimab. Both consist of artificially synthesized copies of the antibodies generated naturally when an immune system fights off infection.

Another monoclonal antibody combination therapy, made by Regeneron, is also authorized in the United States.

In clinical trial results announced last month, high-risk patients with Covid-19 who were given Eli Lilly’s combination therapy were significantly less likely to end up hospitalized than those who received a placebo. No patients who were given the combination therapy died.

The combination therapy must be given via an intravenous infusion. On Tuesday, the F.D.A. said that bamlanivimab alone could now be infused for a period as short as 16 minutes, down from an hour when the therapy was first authorized.

That long infusion time is one reason that monoclonal antibody drugs have not been more widely used in some places. Patients and their families have also struggled to gain access to the therapies. Some hospitals have been too overwhelmed to prioritize the drugs. And some doctors have been hesitant to embrace them, saying that they want to see more evidence from clinical trials supporting the drug’s use.