> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Gives Danicopan Breakthrough Designation
- URL: https://www.fdaweb.com/fda-gives-danicopan-breakthrough-designation/
- Published: 2019-09-25T12:00:00.000Z
- Updated: 2026-09-15T01:52:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145093

FDA has granted breakthrough therapy designation for Achillion Pharmaceuticals’ danicopan for treatment in combination with a C5 monoclonal antibody for patients with paroxysmal nocturnal hemoglobinuria who are sub-optimal responders to a C5 inhibitor alone. The agency’s decision [reportedly](https://www.marketwatch.com/press-release/achillion-receives-breakthrough-therapy-designation-from-fda-for-danicopan-for-treatment-of-paroxysmal-nocturnal-hemoglobinuria-2019-09-25-7184151?ref=fdaweb.com) was based on positive safety and efficacy data from an ongoing Phase 2 trial.