Novartis reports Fabhalta receives positive CHMP opinion

Novartis announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion and recommended granting a marketing authorization for Fabhalta for the treatment of adults with paroxysmal nocturnal hemoglobinuria, or PNH, who have hemolytic anemia. Following the CHMP’s recommendation to approve Fabhalta in adult patients with PNH who have hemolytic anemia, the European Commission will take a final decision within approximately two months, the company noted. “If approved by the European Commission, Fabhalta would be the first oral monotherapy available to PNH patients in Europe. With current standard of care, PNH symptoms are often uncontrolled, while patients endure regular and time-consuming infusions. This oral therapy could provide a much-needed alternative to support many people living with PNH who often have to structure their lives around managing their condition,” said Patrick Horber M.D., President, International, Novartis, Basel.