Vertex Pharma: FDA Grants Inaxaplin Breakthrough Therapy Designation

(RTTNews) - Vertex Pharmaceuticals Incorporated (VRTX) announced the FDA has granted inaxaplin Breakthrough Therapy Designation for APOL1-mediated focal segmental glomerulosclerosis. The Breakthrough Therapy Designation was granted based on the Phase 2 clinical study of inaxaplin in patients with APOL1-mediated FSGS, a form of APOL1-mediated chronic kidney disease.

Also, the European Medicines Agency has granted inaxaplin Priority Medicines designation for APOL1-mediated chronic kidney disease. The PRIME designation was granted based on clinical proof-of-concept data from phase 2 study of inaxaplin in APOL1-mediated FSGS.