The Food and Drug Administration on Tuesday granted emergency use authorization for a Covid-19 therapy combining two monoclonal antibody drugs.
Approval of treatment manufactured by drug maker Eli Lilly gives doctors another option for patients with Covid-19 who are not yet sick enough to be hospitalized, but with a high risk of becoming seriously ill. But while these therapies received an advertising boost from then President Trump and several other politicians who took them while they were sick with Covid-19, the drugs have been surprisingly underutilized in many places – even with hospitalizations triggered during autumn and winter.
Crucially, the researchers are hopeful about the preliminary data suggesting that the new combination therapy may be better able to combat new variants of the virus, compared to a similar treatment already in use. This could make the new combination therapy very valuable as the new variants install themselves.
The newly approved 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 naturally generated when an immune system fights infection.
“With the risk of resistance emerging as multiple strains of the virus emerge, bamlanivimab and etesevimab together can enable efficacy against a wider range of naturally occurring SARS-CoV-2 variants as these new strains spread across the world ”, Dr. Daniel Skovronsky, Eli Lilly’s scientific director, said in a statement.
Eli Lilly said it will produce up to 1 million doses of etesevimab by the middle of this year, with the help of manufacturer Amgen. The company said it has 100,000 doses of etesevimab ready now and would have an additional 150,000 doses by the end of March.
The federal government has agreed to buy about 1.5 million doses of bamlanivimab. The company has already delivered hundreds of thousands of doses, with the rest to be delivered by the end of March. More than 532,000 doses of bamlanivimab have been sent to states and other jurisdictions.
Another monoclonal antibody combination therapy, manufactured by Regeneron, is also authorized in the United States. Almost 100,000 doses of this therapy have been shipped.
In the results of clinical trials announced last month, high-risk patients with Covid-19 who received combination therapy from Eli Lilly were significantly less likely to end up hospitalized than those who received a placebo. No patient who received the combination therapy died.
The FDA said in a statement that the combination therapy may have an important advantage over bamlanivimab alone – reduced risk of so-called resistant variants in patients who have been treated with the therapy. The detection of such variants is a sign that the virus may be able to escape therapy. The agency said the combination therapy “can protect against treatment failure if a patient is infected with a viral variant of SARS-CoV-2 that is resistant to bamlanivimab alone”, although this issue has not been studied in clinical trials. .
Combination therapy should be administered by a healthcare professional through an intravenous infusion lasting at least 21 minutes. On Tuesday, the FDA said that bamlanivimab alone can now be infused for as short as 16 minutes, below an hour when therapy was first authorized.
This long infusion time is one of the reasons why drugs with monoclonal antibodies have not been used more widely in some places. Patients and their families also have difficulty accessing therapies. Some hospitals are overloaded to prioritize medications. And some doctors are hesitant to accept them, saying they want to see more evidence from clinical trials that support drug use.