Vertex Pharmaceuticals VRTX received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its drug candidate inaxaplin (VX-147) for the treatment of patients with APOL1-mediated focal segmental glomerulosclerosis (FSGS).
The FDA grant was supported by the Phase 2 clinical study of inaxaplin in patients with APOL1-mediated FSGS, a form of AMKD.
Additionally, the European Medicines Agency (EMA) has granted inaxaplin Priority Medicines (PRIME) designation for APOL1-mediated chronic kidney disease (AMKD).
The PRIME designation was supported by the clinical proof-of-concept data readout from the Phase 2 clinical study of inaxaplin in APOL1-mediated FSGS.
FDA grants Breakthrough therapy designation (BTD) to expedite the development and review of drugs for serious or life-threatening conditions. The BTD requires preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
Vertex Pharmaceuticals shares are currently higher at $272.75 in the regular trading session.
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