October 14, 2020

The U.S. FDA has approved Inmazeb® (atoltivimab/maftivimab/odesivimab-ebgn), a novel anti-viral antibody medicine manufactured by Regeneron, to treat infections caused by Zaire ebolavirus in adult and pediatric patients, including neonates (newborns) born to a mother who is RT-PCR positive for Zaire ebolavirus infection. Inmazeb is the first FDA-approved treatment for Zaire ebolavirus.

Zaire ebolavirus, more commonly known as the Ebola virus, is one of four species in the Ebolavirus genus that can cause potentially fatal disease in humans. Fatality rates for the virus vary from 25-90% depending on the specific outbreak. Once contracted, Ebola virus infects the body’s immune cells, weakening the immune response, and triggers systemic inflammation and fever that can cause life-threatening organ and tissue damage.

In a clinical trial, treatment with Inmazeb significantly reduced mortality compared to an investigational control drug. Approximately one third (33.8%) of Ebola patients treated with Inmazeb died after 28 days compared to 51% of patients who received the control. The three antibodies contained in Inmazeb work by blocking the Ebola virus’s ability to invade immune cells, and by stimulating healthy immune cells to target and destroy infected cells.

Recommended dosing is 3mL of Inmazeb per kilogram of the patient’s weight administered as a one-time intravenous infusion. The infusion time ranges from 2-4 hours depending on the patient’s weight and total infusion volume after Inmazeb has been mixed with a dilutant for use.

Regeneron has made Inmazeb available in low- and middle-income countries through compassionate use programs and plans to work with non-profit and public health agencies to ensure continued access.

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