'Breakthrough' status for Ridgeback's Ebola candidate mAb114

9 September 2019

The US Food and Drug Administration has recently granted mAb114, an experimental treatment for Ebola from closely-held US biotech firm Ridgeback Biotherapeutics, Breakthrough Therapy designation.

Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions, and the grant was based on interim data from the Pamoja Tulinde Maisha (PALM [together save lives]) study.

"The FDA's decision to grant mAb114 Breakthrough Therapy designation for the treatment of Ebola reflects a recognition of the promising efficacy and safety data that has been collected to date for this investigational drug. We plan to work closely with the FDA as we continue to advance our development program for mAb114. The substantial survival improvement seen with mAb114 in the PALM trial catalyzed this important regulatory milestone," said Wendy Holman, chief executive of Florida-based Ridgeback Biotherapeutics.

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