"BAM-la-nih-VAH-mab" or Bamlanivimab, FDA-approved monoclonal Antibody for Covid-19

 I see physicians online have taken to call this recently-approved monoclonal antibody treatment the "B-word." Just say BAM-la-nih-VAH-mab.

From the November 9th FDA news release: "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."

As Dr. Lawler mentioned in the interview I covered in another blog post, this is an much needed out-patient treatment.

Important to note that the safety and effectiveness evaluation is still ongoing. But so far, "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 has not shown a benefit to patients hospitalized due to COVID-19 or require oxygen therapy, therefore is not authorized for these patients.

The FDA news release goes on to warn: "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."

What is a monoclonal antibody? 

"Monoclonal" means that all these antibodies are identical. In the body, an immune response results in the production of a wide variety of antibodies with different binding strengths. You want your treatment antibody to have high specificity or strong affinity for the invading virus.

A very interesting process is used to manufacture these antibodies. The image at the right starts with mouse immunological spleen cells put in contact with the virus or parts of it believed to elicit an immune response.

These cells are then fused with cancer cells, because the myeloma cells used are virtually immortal, growing prolifically in culture through many generations.

This hybridoma is allowed to grow in culture after which cells producing the specific antibody desired are selected. These cells produce the monoclonal antibodies which are harvested and used for treatment.