FDA grants Ridgeback's mAb114 breakthrough drug
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Last Update: 2020-06-08
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Source: Internet
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Author: User
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recently, Ridgeback Biotherapeutics(http://announced that the u.SFood andDrug(http://Authority (
FDA(http://has granted mAb1114 breakthrough drug eligibility (BTD)May 2019, the FDA also granted mAb114 Orphan Drug (ODD)About mAb114
mAb114 is a monoclonal antibody that originated from the 1995 Ebola outbreak in Kikwete, Democratic Republic of the CongoIn that outbreak, survivors remained anti-Ebola antibodies for up to 11 years after contracting Ebola, and researchers isolated antibodies from those survivors, of which mAb114 was the most promisingTHE PALM STUDY TESTED FOUR THERAPIES, INCLUDING THREE ANTIBODY THERAPIES (ANTIBODY COCKTAIL ZMAPP, THREE MONOANTITIC MIXTURES, REGN-EB3 ( REAMERING ELEMENT), MONOCLONAL ANTIBODY MAB114) AND AN ANTIVIRAL DRUG REMDESVIR (GILEAD), OF WHICH ZMAPP WAS USED AS A CONTROLPreliminary assessments from 499 subjects, published in August, showed that subjects treated with REGN-EB3 and mAb114 had a greater chance of survival than the other two groupsthe specific data were: (1) remdesvir, ZMapp, mAb114, REGN-EB3 treatment of the mortality rate of 53%, 49%, 34%, 29%, (2) in patients treated early after infection and low blood virus levels, the data were stronger, the mortality rate was 33%, 24%, 11%, 6%
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