Vertex wins key FDA and EU designations for kidney disease drug
peterschreiber.media/iStock via Getty Images


Vertex Pharmaceuticals (NASDAQ:VRTX) announced on Wednesday that U.S. and European regulators issued key designations for its kidney disease candidate inaxaplin (VX-147) that would enable the company to speed up its regulatory work.
In the U.S., the FDA has granted its Breakthrough Therapy Designation for inaxaplin in APOL1-mediated focal segmental glomerulosclerosis (FSGS).

Meanwhile, the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation for the candidate in APOL1-mediated chronic kidney disease (AMKD).
FDAâs Breakthrough Therapy designation is aimed at speeding up the development and review of treatments targeted at serious or life-threatening conditions.
With the EMA's PRIME designation, the developers get early and proactive regulatory support for promising medications enabling these drugs to reach patients sooner.

Read why Seeking Alpha contributor Edmund Ingham thinks that Vertex (VRTX) investors will be rewarded with share buybacks and a dividend.