Intellia's CRISPR Therapy Lonvo-z Granted FDA Priority Review for Hereditary Angioedema

Intellia Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for lonvoguran ziclumeran (lonvo-z), a potential one-time treatment for Hereditary Angioedema (HAE). The application has been granted Priority Review, setting a target action date for an FDA decision.

Key Details

• Regulatory Action: The FDA accepted the BLA for lonvo-z and granted Priority Review.
• PDUFA Date: The target action date for an FDA decision is March 10, 2027.
• Significance: If approved, lonvo-z would become the world's first in-vivo CRISPR-based therapy and the only one-time treatment for HAE. The FDA has indicated it does not currently plan to hold an advisory committee meeting to discuss the application.