Posted by Michael Wonder on 07 Sep 2019
Ridgeback Biotherapeutics announces receipt of breakthrough therapy designation from FDA for mAb114
6 September 2019 - Ridgeback Biotherapeutics today announced that the FDA has recently granted mAb114, an experimental treatment for Ebola, breakthrough therapy designation.
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.
