Ionis Pharma's Phase 3 OASIS-HAE Study Of Donidalorsen In Hereditary Angioedema Meets Main Goal

(RTTNews) - Ionis Pharmaceuticals, Inc. (IONS) Monday said Phase 3 OASIS-HAE study of donidalorsen in people with hereditary angioedema (HAE) met its primary goal.

HAE is a rare and life-threatening genetic disease that causes frequent severe swelling of the skin, gastrointestinal tract, upper respiratory system, face and throat.

In the Phase 3 OASIS-HAE study, patients with HAE were randomized to receive either donidalorsen or placebo for 24 weeks. The study met its primary endpoint with a statistically significant reduction in the rate of HAE attacks in patients treated with donidalorsen.

The company said it plans to submit a New Drug Application with the U.S. Food and Drug Administration. Otsuka, which has exclusive rights to commercialize donidalorsen in Europe, is preparing to submit a Marketing Authorization Application to the European Medicines Agency.