- US health officials on Monday approved the pharmaceutical company Eli Lilly’s COVID-19 antibody therapy for emergency use.
- The drugmaker said that in clinical trials, the treatment successfully reduced virus levels, symptoms, and hospitalizations in patients with mild to moderate cases, with no serious side effects.
- The drug is similar to the experimental antibody treatment that President Donald Trump received when he was hospitalized at Walter Reed National Military Medical Centre in October.
- The FDA has granted emergency authorization for other experimental coronavirus treatments, including remdesivir, which is an antiviral.
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The US Food and Drug Administration on Monday authorised emergency use of Eli Lilly’s experimental antibody treatment for COVID-19.
Doctors can now use the drug to treat coronavirus patients who have mild or moderate cases but are at high risk of getting sicker, Eli Lilly said in a statement.
The drug is one of dozens of antibody treatments being developed and studied to treat coronavirus patients. The drugmaker on October 7 submitted an application for its emergency approval.
The treatment is similar to the Regeneron antibody cocktail President Donald Trump received after being diagnosed with COVID-19.
In clinical trials, the monoclonal antibody treatment showed promising results by reducing virus levels, symptoms, and hospitalizations in patients with mild to moderate cases. Researchers also found no serious side effects, the company said. The FDA’s authorization means high-risk patients showing mild to moderate symptoms can be treated with the drug.
The company plans to make up to 1 million doses of the drug available for use around the world by late December. Eli Lilly said it would increase manufacturing significantly next year.
Monoclonal antibody treatments like Eli Lilly’s use synthetically manufactured antibodies similar to those produced by the human immune system and are widely regarded as the best measure for controlling the pandemic until a vaccine is widely available.
The treatment is delivered via intravenous transfusion. Antibody drugs are considered one of the most promising treatments to slow the coronavirus pandemic that’s now killed more than 1 million people worldwide.
“It made me better,” Trump said of his Regeneron antibody treatment in an interview with Fox Business on Thursday. “I didn’t feel great. I think I would have done it fine with no drugs; you don’t need drugs.”
To be sure, Trump received two other treatments for COVID-19, so it’s impossible to say what effect Regeneron’s drug had.
In October, Eli Lilly CEO David Ricks said the company had been in close communication with the White House’s Operation Warp Speed team about the treatment development. He also said the company wanted patients to have “no or very, very low out-of-pocket costs anywhere in the world to receive this therapy.”
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