Therapy Areas: AIDS & HIV
US FDA grants Breakthrough Therapy designation to Ridgeback Biotherapeutics' Ebola treatment
9 September 2019 -

The US Food and Drug Administration (FDA) has granted Ridgeback Biotherapeutics LP, a biotechnology company, Breakthrough Therapy designation for its mAb114, an experimental Ebola treatment, it was reported on Friday.

Breakthrough Therapy designation is intended to accelerate the development and review of drugs for serious or life-threatening conditions.

The criteria for Breakthrough Therapy designation needs preliminary clinical evidence that indicates that the drug is likely to have substantial improvement on around one clinically significant endpoint over available therapy. Breakthrough Therapy designation for mAb114 was based on interim data from the Pamoja Tulinde Maisha (PALM [together save lives]) study, co-sponsored and funded by the INRB (Institut National de Recherche Biomédicale) and the National Institute of Allergy and Infectious Diseases (NIAID) of the US National Institutes of Health and carried out by an international research consortium coordinated by the World Health Organization (WHO).



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