Regeneron's Inmazeb Becomes First FDA-Approved Therapy for Ebola Virus Infection

Today, the U.S. FDA announced the approval of Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn; formerly known as REGN-EB3), a neutralizing antibody cocktail therapy developed by Regeneron, for the treatment of Ebola virus infection in adults and children. This marks the first drug approved by the FDA for the treatment of Ebola virus infection.

Ebola virus can cause potentially fatal human disease. It is transmitted through direct contact with the blood, body fluids, and tissues of infected individuals or wild animals. Individuals providing care to patients with Ebola virus infection, including healthcare workers who do not use appropriate infection control precautions, are at the highest risk of infection.

Inmazeb, developed by Regeneron, targets the glycoprotein expressed on the surface of the Ebola virus. This glycoprotein facilitates the fusion of the viral and host cell membranes by binding to receptors on the cell surface, thereby enabling viral entry into the cell. The three antibodies comprising Inmazeb bind simultaneously to this glycoprotein, blocking viral attachment and cellular entry.

In the multicenter, open-label, randomized controlled trial named PALM, the safety and efficacy of Inmazeb were validated. A total of 154 patients received Inmazeb treatment, while 168 patients received the investigational control. The trial results demonstrated that 33.8% of the 154 patients treated with Inmazeb died within 28 days, compared to a mortality rate of 51% among the 153 patients who received the control treatment. Additionally, 228 other patients were treated with Inmazeb under an expanded access program.

FDA Commissioner Stephen M. Hahn, M.D., stated: “Today’s approval demonstrates the FDA’s commitment to addressing global public health threats through science and data. This approval was made possible by our steadfast dedication to advancing the development of safe and effective treatments for infectious diseases, which is a critical component of our public health mission.”

Currently, Regeneron’s neutralizing antibody cocktail therapy REGN-COV2, developed using the same approach for the treatment of COVID-19, has achieved preliminary positive results in clinical trials and has submitted an application for Emergency Use Authorization to the U.S. FDA.

References:

[1] FDA Approves First Treatment for Ebola Virus. Retrieved October 14, 2020, from https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-ebola-virus

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