Bamlanivimab could prevent hospitalizations in mild and moderate cases
Owensboro Health Regional Hospital recently added Bamlanivimab, a monoclonal antibody therapy, as a potential treatment option for some patients with mild and moderate cases of COVID-19. The new therapy may help patients who meet particular criteria to slow the progression of COVID-19 and possibly avoid hospitalization, one study suggests.
Bamlanivimab was authorized for emergency use by the Food and Drug Administration on Nov. 10, but has not been formally approved by the FDA. However, officials said the known and potential benefits outweigh its known and potential risks.
Bamlanivimab is administered to qualifying patients through infusion therapy — a form of therapy that delivers medication directly into the veins via a sterile catheter. The treatment is a one-time outpatient procedure that takes about an hour to perform; an additional hour of observation is also required.
According to FDA guidelines, Bamlanivimab is designed to be administered as quickly as possible following the onset of a patient’s symptoms.
“As a regional leader in the fight against COVID-19, we are committed to giving western Kentucky and southern Indiana every possible tool to treat this disease and mitigate its effects on patients,” said Debbie Bostic, chief operating officer for OHRH. “The availability of Bamlanivimab gives providers another treatment option that might help some patients avoid hospitalization.”
The FDA’s Emergency Use Authorization, and specifications issued by the drug manufacturer (Eli Lilly and Company), permit the use of Bamlanivimab only for adult and pediatric patients with positive results of direct COVID-19 viral testing and who are at risk for progressing to severe and possible hospitalization.
Patients must be at least 12 years of age, weigh at least 40kg (88.1lb), and have an additional risk factor such as diabetes or chronic kidney disease.
The drug is not authorized for patients who are already hospitalized or undergoing oxygen therapy, either for COVID-19 or other medical conditions.
“Bamlanivimab is designed to help the body’s immune system block the coronavirus from binding to our cells and replicating, which may decrease the viral load and lead to less progression of the disease,” said Michael Kelley, MD, vice president of medical affairs for Owensboro Health. “Although studies are ongoing, early research reviewed by the FDA suggested that the drug may have prevented hospitalizations when compared to the control group.”
An FDA fact sheet (viewable here) says that two of the 850 clinical trial participants have experienced serious reactions to the drug or the infusion, requiring treatment to be stopped. Nausea, diarrhea and headache were among the most common side effects that have been reported during the trial.
Patients who are interested in considering Bamlanivimab as a potential treatment option should discuss it with their doctor, Kelley recommends. Interested providers are invited to consult Owensboro Health’s medical staff services department for more information, 270-417-6840.
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