Last month, the U.S. Food and Drug Administration (FDA) approved remdesivir as the first official antiviral drug for coronavirus. On November 9, the FDA issued an emergency use authorization (EUA) for the drug bamlanivimab to treat mild-to-moderate patients with coronavirus.
LY-CoV555 or bamlanivimab is an antibody drug treatment manufactured by the company Eli Lilly. Phase two clinical trial results have been published in The New England Journal of Medicine where 452 patients received one of three doses of the antibody therapy or a placebo.
Between two and six days of treatment, patients with coronavirus showed signs of improvement. compared to those who received a placebo. Results also determined that a 700-milligram dose was effective against the virus. However, bamlanivimab is only effective for those who are already mildly sick with coronavirus and belong to high-risk groups such as senior citizens, those with pre-existing medical conditions, and cases that are progressing towards severe symptoms.
Who Can Receive Bamlanivimab?
Patients who are hospitalized or are using ventilation machines for oxygen therapy will not benefit from the antibody drug treatment due to the severity of their conditions. This is because the volunteers in the successful clinical trials did not include hospitalized patients and monoclonal antibodies may worsen the condition of patients with high doses of oxygen therapy.
Bamlanivimab is composed of monoclonal antibodies or proteins created in the laboratory that imitate how the immune system attacks viruses and other harmful antigens. The antibody drug was designed to block the spike protein of SARS-CoV-2 from attaching and entering human cells.
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One Step Closer to FDA Approval
The EUA for the antibody treatment is not FDA approval, rather, the agency is expediting the development of the potential treatment to discover its efficacy and risks beyond the previous trials. The agency will also confirm if 700 mg is the most effective dosage since other patients in the trial received a 2,800 mg or 7,000 mg dose of bamlanivimab.
A majority of the patients in the clinical trials cleared the virus after 11 days, including the placebo group. The FDA also noted the importance of bamlanivimab being effective for emergency room cases that may not have severe symptoms of coronavirus.
For now, the EUA will allow health care providers to administer a single dose of bamlanivimab for mild or moderate cases. The authorization will also require Eli Lilly to create a fact sheet containing critical information about the drug such as dosing instructions and potential side effects. Side effects include nausea, diarrhea, dizziness, headache, itching vomiting, and anaphylaxis (allergic reaction).
Dr. Daniel Skovronsky of Lilly Research Laboratories said that the study results supported the company's "belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus." The government has already purchased 3000,000 doses of bamlanivimab.
Lilly has also partnered with the national distributor AmerisourceBergen. The company also anticipates manufacturing one million doses by the end of the year and distribute bamlanivimab globally by early 2021.
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