By Billy Gray
Roche said its Gazyva drug met the key goals in a late-stage trial, significantly reducing symptoms of systemic lupus erythematosus.
The Swiss pharmaceutical group on Monday said the treatment hit the primary goal of the study, with a higher percentage of patients meeting a key improvement metric after one year on the drug versus the standard therapy. The drug, which is marketed as Gazyva in the U.S. and Gazyvaro in the EU, also met all key secondary endpoints.
Roche said it would present the latest trial data at an upcoming medical meeting and share it with medical authorities--including the U.S. Food and Drug Administration and the European Medicines Agency--as soon as possible. If approved, the drug would be the first of its kind treating the disease that directly targets a type of white cells known as B cells, an underlying cause, it added.
Systemic lupus erythematosus affects more than three million people worldwide, most of them women, and around half of patients progress to the potentially fatal kidney complication lupus nephritis within five years of diagnosis, Roche said. Symptoms include frequent flares of activity that inflame and damage several organs, the company said.
Write to Billy Gray at william.gray@wsj.com
(END) Dow Jones Newswires
November 03, 2025 02:05 ET (07:05 GMT)
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