FDA clears Eli Lilly COVID-19 antibody treatment for emergency use

Eli Lilly has obtained emergency use authorization from the Food and Drug Administration for his monoclonal antibody treatment, Bamlanivimab.

Treatment will be used for cases of mild to moderate COVID-19 in high-risk adults, including those 65 years of age or older, or who have certain chronic medical conditions, and children 12 years of age or older and weighing. at least 88 pounds.

This photo provided by Eli Lilly shows the drug Bamlanivimab. On Monday, November 9, 2020, the Food and Drug Administration authorized the emergency use of Bamlanivimab, the first antibody drug to help the immune system fight COVID-19. The drug is for 12 people

Eli Lilly Chairman and CEO David A. Ricks said in a statement that the treatment would be a “valuable tool for doctors who are battling the growing burden of this global pandemic.”

“The rapid development and availability of bamlanivimab could not have been achieved without the hard work of our team at Lilly, collaboration across industry and the urgent work being done by the government to ensure an appropriate allocation for patients who have it. need it most, ”Ricks added. .

Dr Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said the agency “will continue to assess new data on the safety and efficacy of bamlanivimab as it becomes available.”

President Trump urged the FDA to speed up approval of Eli Lilly’s antibody treatment in October with Regeneron’s experimental antibody cocktail. The approval will allow healthcare professionals to offer an alternative treatment option to Gilead’s remdesivir, an investigational drug approved by the FDA last month.

CRITICAL QUESTION RESULTS OF VACCINE TRIALS PFIZER CALENDAR

Although the safety efficacy of this investigational treatment continues to be evaluated, bamlanivimab has been shown in clinical trials to reduce COVID-19-related hospitalizations or emergency room visits in patients with high risk of disease progression within 28 days of treatment compared to placebo.

The drugmaker’s Phase 2 trial involved 452 patients. Of 309 study participants who were injected with Eli Lilly’s drug, five, or 1.6%, were subsequently hospitalized or visited the emergency room, compared with nine of 143 who received placebo, or 6.3%.

Bamlanivimab should be given as a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of onset of symptoms. Bamlanivimab is not allowed in patients hospitalized due to COVID-19 or requiring oxygen therapy due to COVID-19. In addition, there is insufficient data on the use of bamlanivimab during pregnancy. The company recommends using the treatment only if “the potential benefit outweighs the potential risk to the mother and fetus.”

According to the FDA, monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when given to hospitalized patients requiring high-flow oxygen or mechanical ventilation with COVID-19.

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Eli Lilly will immediately begin shipping bamlanivimab to the national distributor AmerisourceBergen, who will distribute it in accordance with the instructions of the US government allocation program.

The U.S. government purchased 300,000 doses of bamlanivimab for $ 375 million and pledged that Americans would not have to pay for the drug, although healthcare facilities may charge administration fees. of the product.

The company plans to manufacture up to 1 million doses of 700 milligrams of bamlanivimab by the end of 2020, with worldwide use early next year after discussions with global regulators. Beginning in the first quarter of 2021, Lilly’s supply of therapeutic antibodies is expected to increase significantly as additional manufacturing resources come online throughout the year.

Administration of bamlanivimab has the potential to cause serious hypersensitivity reactions, including anaphylaxis. Other infusion-related reactions may include fever, chills, nausea, headache, bronchospasm, hypotension, swelling under the skin, irritation of the throat, rash including hives, itching, muscle pain and dizziness.

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