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Today, the FDA announced the approval of Regeneron's development of a medium-antibody cocktail therapy Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn, formerly called REGN-EB3) for the treatment of Ebola virus infection in adults and children.
is the first FDA-approved drug to treat Ebola virus infection.
ebola virus can cause potentially fatal human diseases.
it is transmitted through direct contact with the blood, body fluids and tissues of an infected person or wild animal, and individuals who provide care to people infected with Ebola virus, including health care workers who do not use proper infection control precautions, are at the highest risk of infection.
inmazeb was developed by Regenerative Meta, which targets glycoproteins expressed on the surface of the Ebola virus.
this glycoprotein, by combining with a subject on the cell surface, causes the virus to fuse with the host cell membrane, allowing the virus to enter the cell.
antibodies that make up Inmazeb can bind to this glycoprotein at the same time, blocking the virus from attaching to and entering cells.
the safety and effectiveness of Inmazeb in a multi-center, open-label, randomized controlled trial called PALM.
154 patients were treated with Inmazeb and 168 patients were given experimental controls.
trial results showed that 33.8 percent of the 154 patients treated with Inmazeb died after 28 days, compared with 51 percent of the 153 patients treated with control.
in the expanded use program, another 228 patients received Inmazeb treatment.
Currently, REGEN-COV2, a meso-antibody cocktail therapy developed by Regenerative Meta using the same method to treat new coronavirus infections, has achieved initial positive results in clinical trials and has submitted an application for authorization for emergency use to the FDA.
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