Pharma Focus Asia

Ridgeback Biotherapeutics LP announces receipt of Breakthrough Therapy designation from FDA for mAb114

Saturday, September 07, 2019

Ridgeback Biotherapeutics LP, a closely held biotechnology company, today announced that the Food and Drug Administration has recently granted mAb114, an experimental treatment for Ebola, Breakthrough Therapy designation.

Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.  Breakthrough Therapy designation 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.  We are grateful to our PALM partners for all of their help in advancing treatments for Ebola patients and our ultimate gratitude goes to the study's participants and their families.  Their trust and support will change the course of this disease," said Wendy Holman, CEO of Ridgeback Biotherapeutics.

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