dm+d

Unassigned

New Medicines

Ebola virus infection treatment

Information

New molecular entity
Ridgeback Biotherapeutics
Ridgeback Biotherapeutics

Development and Regulatory status

None
Phase III Clinical Trials
Approved (Licensed)
Dec 20Approved by FDA for the treatment of Ebola in adult and paediatric patients [4].
Jul 20US FDA accept BLA for Priority Review [3].
Sep 19FDA grant mAb114 Breakthrough Therapy Designation [3].
Aug 19Trials being conducted in DRC (Democratic Republic of Congo) [1].

Category

Monoclonal antibody based on antibodies from an Ebola survivor
Natural Ebola outbreaks occur most often in African countries, the most recent from 2014 through 2016. According to the World Health Organization, during that outbreak more than 28,600 cases of Ebola virus infection were suspected, probable or confirmed and more than 11,000 people died [2].
Ebola virus infection treatment
Intravenous

Trial or other data

Sep 19PALM study is co-sponsored, funded and supported by the INRB (Institut National de Recherche Biomédicale) the US National Institute of Allergy and Infectious Diseases (NIAID) and the World Health Organization (WHO). The trial had enrolled nearly 700 participants across four Ebola Treatment Centers in the DRC. With the preliminary findings in 499 trial participants, REGN-EB3 and mAb114 will be the two investigational treatments given as part of an Extension Phase study [1].