WASHINGTON (NewsNation Now) — The U.S. Government has approved an Emergency Use Authorization for an investigational monoclonal antibody therapy “for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients,” the agency said Monday.

The drug bamlanivimab, developed by Eli Lilly, is one of several therapies being investigated for COVID-19.

“While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” the agency said in a statement.

There are restrictions for the EUA:

• Positive results of direct SARS-CoV-2 viral testing
• Must be 12 years of age and older weighing at least 88 pounds
• At high risk for progressing to severe COVID-19 and/or hospitalization
• This includes those who are 65 years of age or older, or who have certain chronic medical conditions
• Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19

“As illustrated by today’s action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn said in a statement. “Through our Coronavirus Treatment Acceleration Program, the FDA continues to work around the clock and use every tool at our disposal toward these efforts.”

The U.S. government agreed last month to buy initial doses of an experimental drug that patients could receive if federal regulators allow it on an emergency basis.

Under the agreement, the government will spend $375 million to buy 300 million vials of the drug. How many doses that would provide is unclear. Each vial contains 70 milligrams and that dose proved ineffective in the early results. It took four times that amount — 2,800 milligrams — to show any effect.

Also in October, the government stopped a study of Lilly’s drug in hospitalized patients after it seemed the drug was not helping those more seriously ill patients.

“This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients — adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic,” said David A. Ricks, Lilly’s chairman and CEO said in a statement. “The rapid development and availability of bamlanivimab could not have been achieved without the relentless work of our Lilly team, collaboration across the industry and the urgent work being done by the government to ensure appropriate allocation to patients who need it the most.”

Regeneron Pharmaceuticals Inc. also is seeking emergency use for its experimental two-antibody treatment. President Donald Trump received it when he was ill with the coronavirus earlier this month.

In September, NewsNation looked at the antibodies, how the therapy is already being used to fight other common conditions like asthma, allergies, arthritis and even cancer.

“The issuance of an EUA is different than FDA approval. In determining whether to issue an EUA, the FDA evaluates the available evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency,” the FDA said Monday.

Also on Monday, Pfizer says early analysis of its COVID-19 vaccine data suggests the shots may be 90% effective at preventing the virus.

Full EUA

Full FDA Statement

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.

While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.

Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. A benefit of bamlanivimab treatment has not been shown in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

“As illustrated by today’s action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, M.D. “Through our Coronavirus Treatment Acceleration Program, the FDA continues to work around the clock and use every tool at our disposal toward these efforts.”

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

“The FDA’s emergency authorization of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research. “We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available.”

The issuance of an EUA is different than FDA approval. In determining whether to issue an EUA, the FDA evaluates the available evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. Based on the FDA’s review of the totality of the scientific evidence available, the agency determined that it is reasonable to believe that bamlanivimab may be effective in treating non-hospitalized patients with mild or moderate COVID-19. And, when used to treat COVID-19 for the authorized population, the known and potential benefits outweigh the known and potential risks for the drug. There are no adequate, approved and available alternative treatments to bamlanivimab for the authorized population. As part of the evaluation of the EUA, the agency imposed several quality measures to protect patients. The company is required to implement these quality measures to manufacture this drug under the EUA.

The data supporting this EUA for bamlanivimab are based on an interim analysis from a phase two randomized, double-blind, placebo-controlled clinical trial in 465 non-hospitalized adults with mild to moderate COVID-19 symptoms. Of these patients, 101 received a 700-milligram dose of bamlanivimab, 107 received a 2,800-milligram dose, 101 received a 7,000-milligram dose and 156 received a placebo within three days of obtaining the clinical sample for the first positive SARS-CoV-2 viral test.

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

The EUA allows for bamlanivimab to be distributed and administered as a single dose intravenously by health care providers. The EUA requires that fact sheets that provide important information about using bamlanivimab in treating COVID-19 be made available to health care providers and to patients and caregivers, including dosing instructions, potential side effects and drug interactions. Possible side effects of bamlanivimab include: anaphylaxis and infusion-related reactions, nausea, diarrhea, dizziness, headache, itching and vomiting.

The EUA was issued to Eli Lilly and Company.

FDA STATEMENT

Full Eli Lilly Statement