argenx discontinues phase 3 trial for Sjögren’s disease drug
Argenx SE has decided to halt its Phase 3 UNITY study of efgartigimod subcutaneous for adults with moderate-to-severe Sjögren's disease. The decision follows a recommendation from an Independent Data Monitoring Committee, which concluded the trial was destined to fail. Efgartigimod had no new safety signals identified. The UNITY study, a randomized, double-blind, placebo-controlled, multicenter trial, aimed to assess the drug's efficacy, safety, and tolerability.
The company expressed disappointment, particularly for patients suffering from Sjögren's disease, who are still waiting for effective treatments. Sjögren's disease is an autoimmune disorder that primarily affects women, with a 9:1 female-to-male incidence ratio. Efgartigimod is already approved for other conditions in Japan, but not for Sjögren's disease.
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