Vertex Pharma to Submit Kidney-Disease Drug Application to FDA by Year-End

By Adriano Marchese

Vertex Pharmaceuticals plans by year-end to submit part of a license application to regulators for its kidney-disease treatment, and to have the full application submitted by first half of next year.

The Boston biotechnology company said Friday that the decision came after the Food and Drug Administration granted a breakthrough-therapy designation to its investigational drug povetacicept for the treatment of IgA nephropathy.

IgA nephropathy is a kidney disease caused by a buildup of a protein called IgA in the kidneys, which leads to inflammation and damage over time. Povetacicept treats IgA by helping to calm the immune system by blocking signals that make certain immune cells overactive.

As part of the FDA's rolling review of the biologics license application, Vertex expects to submit the first module to the regulator for potential accelerated approval before the end of 2025, and said it remains on track to complete the full BLA submission for accelerated approval in the U.S. in the first half of 2026.

Vertex also started a major clinical trial called Olympus, a phase 2b/3 study to test povetacicept for treating primary membranous nephropathy, an autoimmune kidney disease.

This is the second indication for which the drug might be one of the best options available, Vertex said, noting that there aren't currently any treatments officially approved specifically for PMN.

Write to Adriano Marchese at adriano.marchese@wsj.com

(END) Dow Jones Newswires

October 17, 2025 10:19 ET (14:19 GMT)