After rocky hep C path, Achillion finds surer footing with FDA breakthrough status

Achillion’s promising proof-of-concept data for its latest drug has won breakthrough status at the FDA.

The US regulator granted its coveted designation to danicopan as a treatment for anemia in paroxysmal nocturnal hemoglobinuria patients taking the mainline C5 inhibitor treatment Soliris. Up to 75% of PNH patients suffer from anemia even after treatment, according to Achillion, with up to a third requiring blood transfusions in the past year.