FDA,埃博拉治疗药物 z-bo 2020-10-22 311

　　Inmazeb has received the "orphan drug" designation, and the FDA has also granted it a breakthrough therapy designation.

　　On October 14, local time, the US Food and Drug Administration (FDA) approved the listing of Inmazeb, a neutralizing antibody cocktail therapy developed by Regeneron, for the treatment of Ebola virus infections in adults and children. This is the first drug approved by the FDA to treat Ebola virus infection.

　　Ebola virus is a severe infectious disease virus that can cause Ebola hemorrhagic fever in humans and other primates. It can pass through the blood, body fluids, secretions, excreta and contamination of infected patients and animals. The death rate of infected patients is 50%-90%.

　　Although the FDA approved the first Ebola vaccine Ervebo in December 2019, it is still blank in the field of therapeutic drugs. Remdesivir, which was used to treat the fire due to new coronary pneumonia, was used to treat Ebola virus in 2018 and was not approved by the FDA for marketing due to its relatively poor efficacy.

　　Inmazeb, which was approved for marketing this time, is a new type of antiviral antibody drug that was once called REGN-EB3. The drug consists of three similarly structured monoclonal antibodies atoltivimab, maftivimab and odesivimab-ebgn, which target the glycoprotein on the surface of the Ebola virus to prevent it from invading the human body.

　　In a deep vein patency trial involving 681 Ebola patients initiated in 2018, the safety and effectiveness of Inmazeb were verified. Patients receiving the therapy had a mortality rate of about one-third after 28 days, compared with the control About half of the group died. The related report was published on NEJM in December 2019.

　　At present, Inmazeb has received the "orphan drug" designation, and the FDA has also granted it a breakthrough therapy designation.

　　FDA Commissioner Stephen M. Hahn said: "The approval of Inmazeb for marketing demonstrates the FDA’s continued commitment to respond to public health threats at home and abroad based on science and data. As part of the public health mission, the FDA is firmly committed to Promote the development of safe and effective treatments for infectious diseases."

　　It is reported that the US government has funded the research and development of the drug and plans to purchase thousands of doses of the drug in the next six years for the national strategic reserve.