FDA grants breakthrough status to Achillion drug

Achillion Pharmaceuticals reports that the FDA has granted Breakthrough Therapy designation for danicopan (ACH-4471) for treatment in combination with a C5 monoclonal antibody for patients with paroxysmal nocturnal hemoglobinuria (PNH) who are sub-optimal responders to  a C5 inhibitor alone.

“The FDA designation underscores the urgent need for new treatment options for patients living with PNH,” said Joe Truitt, President and Chief Executive Officer at Achillion. more