REGENERON'S INMAZEB FIRST PRODUCT TO RECEIVE FDA APPROVAL FOR TREATING EBOLA VIRUS
The U.S Food and Drug Administration has announced the approval of Inmazeb (atoltivimab, maftivimab, and odesivimab) for treating the Ebola virus. The drug is approved for treating adults, pediatrics, and newborns tested positive for the Ebola virus.
The drug approval is based on the clinical trial, which enrolled 382 patients with confirmed Zaire ebolavirus. One hundred fifty-four patients were treated with Inmazeb (50 mg of each monoclonal antibody) intravenous infusion, and 168 patients were treated with control. 28-day mortality was considered as the primary endpoint. Among the patients treated with Inmazeb, 33.8% of patients died than 51% of the control group.
Patients who were on Inmazeb should avoid the use of the vaccine, as Inmazeb can inhibit the replication of the vaccine.
Hypersensitivity can occur in the patients on Inmazeb; in that case, the treatment should be stopped. The drug has received orphan designation, breakthrough therapy designation.
Mechanism of action of Inmazeb
The drug acts by targeting the glycoprotein present on the surface of the Ebola virus. The glycoprotein of the virus helps in attaching to the human cells and integrating with the human cells. The three antivirals inhibit the glycoprotein's attachment, thereby preventing the attachment and entry of the virus.
About Ebola virus
Zaire ebolavirus, commonly known as the Ebola virus, causes a potentially fatal human disease. The virus is usually transferred through direct contact with blood, blood fluids, and tissues of the infected patients or wild animals, surfaces that are contaminated with the fluids.