Treatment is intended for mild to moderate coronavirus cases, but not suitable for hospital patients, the regulator says. Lilly shares are soaring on the news.
The U.S. Medicines Agency has approved the emergency use of Eli Lilly’s experimental COVID-19 antibody treatment for non-hospitalized patients with mild to moderate symptoms.
The Food and Drug Administration (FDA) said its approval was based on clinical studies showing that treatment with bamlanivimab reduced the need for hospitalization or emergency room visits in COVID-19 patients at high risk of the disease getting worse.
It can now be used to treat mild to moderate COVID-19 in patients over the age of 12. The drug can also be prescribed to patients over the age of 65 or with certain chronic conditions, according to the FDA.
However, antibody treatment is not approved for patients who are hospitalized for COVID-19 or who require oxygen therapy because of COVID-19. The FDA said the drug, which US President Donald Trump has praised, has not been shown to benefit such patients and could worsen their clinical status.
A US government-sponsored study of treating COVID-19 patients in the hospital was recently canceled because the treatment was found to be of no help.
According to Pfizer, the experimental COVID-19 vaccine is more than 90 percent effective [File: Dado Ruvic/Reuters]Also on Monday, US drug maker Pfizer said its experimental COVID-19 vaccine was more than 90 percent effective. This is an important victory in the fight against the pandemic which killed more than a million people, affected the global economy and changed daily life.
The news sparked stock markets in hopes that the vaccine would help hasten the recovery from the worst global economic downturn since the Great Depression.
In early October, Eli Lilly applied for emergency approval for single antibody therapy. Findings 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 percent of those who received the antibody infusion had to be hospitalized or needed an emergency medical visit. compared to 6.3 percent of those who received a placebo.
Double whammy
The company announced that it would file for similar approval in November for its two-antibody cocktail, which has helped lower virus levels even further than single-antibody treatment.
Both treatments are monoclonal antibodies – a widely used class of biotech drugs, which are synthetic copies of antibodies developed by the human body to fight infections.
Lilly expects to ship up to one million doses of single antibody therapy in the fourth quarter, with 100,000 doses available by October. A contract has been signed with the US government for $ 1,250 per dose and the treatment is planned to be sold to other countries.
Lilly said in a statement that bamlanivimab should be given “as soon as possible after a positive Covid-19 test and within 10 days of symptoms appearing”.
Lilly will immediately ship the antibody therapy to AmerisourceBergen Corp, who will distribute it according to instructions from the US government. People in the United States will not have an out-of-pocket cost of the drug, the company said, while recognizing that healthcare facilities may charge a fee for giving the product intravenously.
The shares of the drug maker from Indianapolis, which closed barely any changes in regular trading at USD 142.33, rose 3.6 percent after hours.
Several other drug manufacturers, including Regeneron Pharmaceuticals Inc, are testing antibody treatments for COVID-19.
Regeneron’s antibody treatment was given to Trump after he caught the virus in early October. The nation’s leading expert on infectious diseases, Dr. Anthony Fauci said this likely helped his recovery.
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