With input from Dr Monica Vasudev

1144:  FDA OKs First Monoclonal Antibody Therapy for COVID-19

Eli Lillys bamlanivimab has become the first monoclonal antibody drug for the treatment COVID-19 patients to receive the FDA’s emergency use authorization (EUA). The drug is authorized for the treatment of mild to moderate COVID-19 in both adult and pediatric patients weighing at least 88 pounds and at high risk of progressing to severe disease. The treatment is to be administered intravenously as a single dose by healthcare providers. It is not meant for patients hospitalized with severe COVID-19 or who require oxygen therapy. It may be associated with worse outcomes among hospitalized patients requiring high-flow oxygen or mechanical ventilation. This is a recombinant monoclonal antibody targeting the SARS-CoV-2 spike protein.

Authorization was based on an interim analysis of a phase II trial involving 465 non-hospitalized adults with COVID-19 symptoms. Patients were randomly allocated to receive 700, 2,800 or 7,000 mg of bamlanivimab or placebo within 3 days of testing positive for SARS-CoV-2. Effects on viral load, hospital visits and safety were found to be similar in all three doses groups.

The drug’s effectiveness for the secondary endpoint of hospitalizations or emergency room visits within 28 days after treatment was also impressive (3% in intervention vs 10% in placebo).

The primary endpoint was change in viral load from baseline to day 11, with most patients, including those in the placebo group, clearing the virus within the timeframe.

Side effects of the drug include anaphylaxis and infusion-related reactions, nausea, diarrhea, dizziness, headache, itching and vomiting.