For immediate release:

Today, the United States Food and Drug Administration issued an Emergency Use Authorization (EUA) for the investigational treatment with bamlanivimab monoclonal antibodies for the treatment of mild to moderate COVID-19 in adult and pediatric patients . Bamlanivimab is approved for use in patients with positive direct viral test results for SARS-CoV-2, aged 12 years and older, weighing at least 40 kilograms (approximately 88 pounds) and at high risk of progressing to Severe COVID-19 and / or hospitalization. This includes people who are 65 years of age or older or who have certain chronic conditions.

Although the safety and efficacy of this investigational treatment continue 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.

Bamlanivimab is not allowed in patients hospitalized due to COVID-19 or requiring oxygen therapy due to COVID-19. Benefit from treatment with bamlanivimab has not been demonstrated in patients hospitalized with COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when given to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

“As today’s action illustrates, the FDA remains committed to accelerating the development and availability of potential treatments for COVID-19 and providing sick patients with rapid access to new therapies, where appropriate. , while supporting research to further assess whether they are safe and effective, “said FDA Commissioner Stephen M. Hahn, MD.” Through our Coronavirus Treatment Acceleration Program, the FDA continues to work 24 hours a day and use all the tools at our disposal for these efforts.

Monoclonal antibodies are lab proteins that mimic the ability of the immune system to fight harmful antigens such as viruses. Bamlanivimab is a monoclonal antibody specifically directed against the SARS-CoV-2 spike protein, designed to block virus attachment and entry into human cells.

“The emergency clearance of bamlanivimab by the FDA provides healthcare professionals on the front lines of this pandemic with another potential tool in the treatment of patients with COVID-19,” said Patrizia Cavazzoni, MD, interim director from the FDA’s Center for Drug Evaluation and Research. “We will continue to assess new data on the safety and effectiveness of bamlanivimab as it becomes available.”

Issuing an EUA is different from FDA approval. In determining whether to issue an EUA, the FDA assesses the available evidence and carefully balances any known or potential risks with the known or potential benefits of the product for emergency use. Based on the FDA’s review of all of the available scientific evidence, the agency determined that it was reasonable to believe that bamlanivimab could be effective in treating outpatients with mild or mild COVID-19. moderate. And, when used to treat COVID-19 for the licensed population, the known and potential benefits outweigh the known and potential risks of the drug. There is no adequate, approved and available alternative treatment to bamlanivimab for the licensed population. As part of the EUA’s assessment, the agency imposed several quality measures to protect patients. The company is required to implement these quality measures to manufacture this medicine under the EUA.

The data supporting this EUA for bamlanivimab is based on an interim analysis of a randomized, double-blind, placebo-controlled phase two clinical trial in 465 outpatient adults with mild to moderate symptoms of COVID-19. Of these patients, 101 received a dose of 700 milligrams of bamlanivimab, 107 received a dose of 2800 milligrams, 101 received a dose of 7,000 milligrams and 156 received a placebo within three days of obtaining the sample. clinic for the first SARS-CoV-positive. 2 viral test.

The pre-specified primary endpoint in the phase two trial was the change in viral load from baseline to day 11 for bamlanivimab compared to placebo. Most patients, including those given a placebo, cleared the virus by day 11. However, the most important evidence for the effectiveness of bamlanivimab came from the predefined secondary endpoint of COVID-19-related hospitalizations or hospital visits. emergency within 28 days of treatment. For patients at high risk of disease progression, hospitalizations and emergency room visits were observed in 3% of patients treated with bamlanivimab on average, compared with 10% of patients on placebo. The effects on viral load and reduction in hospitalizations and emergency room visits, and on safety were similar in patients receiving any of the three doses of bamlanivimab.

The EUA authorizes the distribution and administration of bamlanivimab as a single intravenous dose by healthcare providers. The EUA requires that information sheets providing important information on the use of bamlanivimab in the treatment of COVID-19 be made available to healthcare providers and patients and caregivers, including dosing instructions, potential side effects and drug interactions. Possible side effects of bamlanivimab include: anaphylaxis and infusion reactions, nausea, diarrhea, dizziness, headache, itching and vomiting.

The EUA was issued to Eli Lilly and Company.

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biologicals for human use, and medical devices . The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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