Emergency Use of a COVID-19 Antibody Drug Allowed by U.S. FDA

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Health officials from the United States permitted the emergency use of the first antibody-drug that aids the immune system in fighting COVID-19 to treat mild to moderate COVID-19 infections in adult and pediatric patients.

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According to U.S. Food and Drug Administration (FDA) release, the said drug is authorized for patients with positive results of direct SARS-CoV-2 viral testing, aging from 12 years and older with at least 40 kilograms. FDA added that the recipient should also have a high risk for progressing to severe COVID-19 or hospitalization.

Also called Bamlanivimab, the antibody-drug is not yet approved for use. The FDA supposed that the said drug was presented in clinical trials to diminish COVID-19 associated hospital admissions or emergency room appointments in patients at high peril for disease development within 28 days after treatment compared to placebo. According to the Los Angeles Times, a study of the drug in the hospitalized patients was stopped when independent monitors saw that the drug did not have any help in the situation.

Although with restrictions and go signal for emergency use on some patients, U.S. FDA stressed in their release that bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or patients who need oxygen therapy because of the disease. They added that monoclonal antibodies such as bamlanivimab might be connected with worse clinical outcomes when given to COVID-19 hospitalized patients that need mechanical ventilation.

FDA on their authorization

According to FDA commissioner Stephen M. Hahn M.D., the FDA remains committed to expediting the development and availability of potential COVID-19 medication and providing ill patients judicious access to new therapies where suitable while simultaneously supporting research evaluate the drug's safety and effectiveness.

FDA also mentioned that the issued Emergency Use Authorization (EUA) for bamlanivimab is based on an interim analysis from phase 2, randomized, double-blind, placebo-controlled clinical trial in 465 non-hospitalized adults with mild to moderate COVID-19 symptoms.

According to the Los Angeles Times, the government previously reached an agreement to buy and supply the early production of bamlanivimab. They added that the said medication is a part of biologic therapies that proposes an auspicious new approach in foiling the serious disease from COVID-19. Los Angeles Times furthered that the drugs are laboratory-made versions of antibodies, blood proteins that the body creates to help target and eliminate infections.

What is Bamlanivimab?

According to Lilly's fact sheet, bamlanivimab is an investigational medicine used for COVID-19 in non-hospitalized adults and adolescents adhering to the U.S. FDA criteria to receive the medication. It is administered intravenously (IV) for at least 1 hour. The fact sheet also added that a patient would receive one dose of bamlanivimab through an IV. Lilly also instructed that patients inform the healthcare provider about their allergy, pregnant, or planning to become pregnant, breastfeeding, have serious illnesses, or take any prescribed medication before receiving bamlanivimab. They also mentioned possible side effects in the fact sheet and encouraged the patients to notify the healthcare providers immediately if they occur.

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