Intellia BLA Gets Priority Review for Hereditary Angioedema

FDA has accepted for priority review an Intellia Therapeutics BLA for lonvo-z, an in vivo CRISPR-based therapy for treating hereditary angioedema (HAE). The agency has set a user fee review action target date of 3/10/2027.

The BLA is based on data from Intellia’s global Phase 3 HAELO clinical trial involving 80 patients. “HAELO met its primary and all key secondary endpoints, demonstrating an 87% reduction (p<0.0001) in mean monthly attacks for lonvo-z compared with placebo during the efficacy evaluation period (weeks 5 to 28),” the company says. “In addition, 62% of patients in the lonvo-z arm were entirely attack free and HAE therapy free for the six-month efficacy evaluation period, compared with 11% of patients in the placebo arm (p<0.0001). As of the February 10, 2026 data cutoff, all patients who received lonvo-z at baseline or in crossover after week 28 remained free from long-term prophylaxis therapy.”