FDA accepts Intellia’s application for a one-time in vivo CRISPR treatment for hereditary angioedema
Now Possible · Friday, 11 September 2026
Why it matters
If approved, lonvo-z could move in vivo CRISPR gene editing from human trial evidence into clinical treatment and become a one-time option for patients aged 16 and older with Type 1 or Type 2 hereditary angioedema. The capability is currently at the regulatory-review stage, with availability, price, treatment centers, and long-term access still unresolved.
What happened
The FDA accepted Intellia Therapeutics’ biologics application for lonvo-z and granted it Priority Review, setting a target decision date of March 10, 2027. Intellia reports that its 80-patient Phase 3 HAELO trial found an 87% reduction in mean monthly hereditary-angioedema attacks versus placebo; 62% of treated patients were attack-free and off HAE therapy during the six-month evaluation period, compared with 11% on placebo. Lonvo-z remains investigational: Priority Review is not approval, and the treatment is not yet available to patients.
Players & places
- United States
- Intellia Therapeutics
- US Food and Drug Administration