Drugmaker Eli Lilly said Wednesday that it has requested an emergency use authorization from the Food and Drug Administration for its Covid-19 monoclonal antibody treatment.
Lilly’s medication is similar to the Regeneron antibody treatment President Donald Trump received after his Covid-19 diagnosis. Regeneron has not yet applied for such an authorization.
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Lilly’s request comes nearly a month after the company announced partial results from a trial of the drug, which suggested it could help keep patients with mild to moderate forms of the illness from progressing to a point where they would need to be hospitalized. Those trial results have not yet been published or peer-reviewed, however.
The company’s chief scientific officer, Dr. Daniel Skovronsky, said the company’s data “provide sufficient evidence” that the therapy “may be effective to treat COVID-19 in patients with a high risk for serious outcomes.”
Lilly’s drug is currently being studied in National Institutes of Health-sponsored clinical trials both as a treatment and for prevention in people who have been exposed.
If the FDA authorizes the treatment for emergency use, it would help physicians access the drug outside of clinical trials.
Lilly is already manufacturing the drug, and expects to have 100,000 doses available this month. The supply could reach as many as 1 million doses by the end of the year.
Monoclonal antibodies are made in a lab to mimic the body’s natural antibodies. The antibodies act by recognizing specific germs — in this case, SARS-CoV-2, the virus that causes Covid-19 — and harnessing the immune system to fight them off.
Though clinical trials are ongoing, the therapy is considered by experts to be one of the most promising treatment options for the illness.
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Also Wednesday, Lilly announced interim data from a study that looked at a combination of two monoclonal antibodies on Covid-19. (The Regeneron treatment that Trump received was a combination of two monoclonal antibodies.) The phase 2 trial, which included 268 study participants, showed the combination “reduced viral load, symptoms and hospitalizations,” the company said in a statement to the media.
Lilly said it plans to ask the FDA for emergency use authorization of that combination treatment in November.
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