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The Food and Drug Administration on Tuesday granted an emergency use authorization for a Covid-19 therapy combining two monoclonal antibody drugs.
The approval of the treatment made by drug maker Eli Lilly gives doctors another option for patients with Covid-19 who are not yet sick enough to be hospitalized but are at high risk of becoming seriously ill. But even though these therapies received a publicity boost from President Trump and several other politicians who took them while sick with Covid-19, the drugs have been surprisingly underused in many places. – even as hospital admissions have skyrocketed throughout the fall and winter.
Importantly, the researchers are optimistic about preliminary data suggesting that the new combination therapy may be better able to fight the newer 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 take hold.
The newly approved therapy combines the company’s drug known as bamlanivimab – which was cleared in November and is being used for high-risk Covid-19 patients – with a second drug called etesevimab. Both consist of artificially synthesized copies of antibodies generated naturally when an immune system fights infection.
“With the risk of resistance emerging when various strains of the virus emerge, bamlanivimab and etesevimab together could potentially provide efficacy against a wider range of natural variants of SARS-CoV-2 as these new strains spread around the world. “Dr Daniel Skovronsky Said Scientific Director Eli Lilly in a statement.
Eli Lilly has said he will produce up to 1 million doses of esevimab by the middle of this year, with manufacturing assistance from drug maker Amgen. The company said it had 100,000 doses of esevimab ready now and would have an additional 150,000 doses by the end of March.
The federal government has agreed to purchase almost 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 shipped to states and other jurisdictions.
Another combination of monoclonal antibodies, manufactured by Regeneron, is also licensed in the United States. Almost 100,000 doses of this therapy have been shipped.
In clinical trial results announced last month, high-risk patients with Covid-19 who received Eli Lilly’s combination therapy 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 fact sheet that the combination therapy could potentially have a key advantage over bamlanivimab alone – a reduced risk of so-called resistant variants in patients who have been treated with the therapy. Detection of such variants is a sign that the virus may be able to escape therapy. The agency said that the combination therapy “may protect against treatment failure if a patient is infected with a viral variant of SARS-CoV-2 resistant to bamlanivimab alone”, although this question has not yet been answered. studied in clinical trials.
Combination therapy should be given by a healthcare professional via an intravenous infusion lasting as short as 21 minutes. On Tuesday, the FDA said bamlanivimab alone can now be infused for as little as 16 minutes, up from an hour when treatment was first cleared.
This long infusion time is one reason why monoclonal antibodies have not been more widely used in some places. Patients and their families also struggled to access therapy. Some hospitals have been too overwhelmed to prioritize drugs. And some doctors were reluctant to adopt them, saying they wanted to see more clinical trial evidence supporting the use of the drugs.
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