Roche says CHMP recommends expansion of EU label for Hemlibra

Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, has recommended expansion of the Hemlibra European Union marketing authorization. If approved, Hemlibra would also be indicated for the routine prophylaxis of bleeding episodes in people with hemophilia A without factor VIII inhibitors, who have moderate disease with a severe bleeding phenotype. It is estimated that people with moderate hemophilia A make up 14% of the hemophilia A population, the company noted.