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The treatment is meant for mild to moderate coronavirus cases but is not suitable for hospitalized patients, the regulator says. Lilly’s shares jump on the news.
The U.S. drug regulator has cleared emergency use of Eli Lilly’s investigational COVID-19 antibody treatment for out-of-hospital patients with mild to moderate symptoms.
The Food and Drug Administration (FDA) said its authorization is based on clinical studies showing that the treatment, bamlanivimab, reduced the need for hospitalization or emergency room visits in COVID-19 patients at high risk of worsening their disease.
It can now be used to treat mild to moderate COVID-19 in patients over 12 years of age. Those over 65 or with certain chronic medical conditions may be prescribed the drug, the FDA said.
But antibody treatment is not authorized for patients admitted to hospital due to COVID-19 or who need oxygen therapy due to COVID-19. The FDA said the drug, which US President Donald Trump praised, has not been shown to benefit such patients and could worsen their clinical status.
A U.S. government-sponsored study of treatment in hospitalized COVID-19 patients was recently abandoned because treatment has not been shown to help.
Pfizer Says Its Experimental COVID-19 Vaccine Is Over 90% Effective [File: Dado Ruvic/Reuters]
Also on Monday, US drug maker Pfizer said its experimental COVID-19 vaccine is over 90% effective, a big win in the fight against the pandemic that killed more than a million people, battered the world economy. and upset the daily life.
The news raised equity markets in hopes that the vaccine would help accelerate the recovery from the worst global economic downturn since the Great Depression.
In early October, Eli Lilly applied for emergency use clearance for her single antibody therapy. Results from a study of 452 patients with mild to moderate COVID-19, published in a peer-reviewed journal in late October, found that 1.6% of those who received the antibody infusion needed to be hospitalized. in the hospital or required an emergency room visit, compared with 6.3 percent of those who received a placebo.
Double shot
The company said it plans to get similar clearance in November for its two-antibody cocktail, which it described as helping to reduce viral levels even more than treatment with a single antibody.
Both treatments are monoclonal antibodies, a widely used class of biotech drugs that are synthetic copies of antibodies created by the human body to fight infections.
Lilly plans to deliver up to one million doses of single antibody therapy in the fourth quarter, with 100,000 doses available in October. It reached a $ 1,250 per dose deal with the US government and plans to sell the treatment to other countries.
Lilly said in a statement that bamlanivimab should be administered “as soon as possible after a positive Covid-19 test and within 10 days of onset of symptoms.”
Lilly will begin shipping the antibody therapy immediately to AmerisourceBergen Corp, which will distribute it as directed by the US government. People in the United States will not have direct costs for the medicine, the company said, while acknowledging that healthcare facilities may charge a fee for intravenous administration of the product.
Shares of the Indianapolis pharmaceutical company, which closed little changed at $ 142.33 in regular trading, were up 3.6% after closing time.
Several other drug manufacturers, including Regeneron Pharmaceuticals Inc, are testing antibody treatments for COVID-19.
Regeneron’s antibody treatment was given to Trump after contracting the virus in early October. Anthony Fauci, the nation’s foremost expert on infectious diseases, said it likely contributed to his recovery.
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