CHMP recommends rFXIII (Novo Nordisk) for FXIII A-subunit Deficiency

Novo Nordisk has announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the recombinant factor XIII product (rFXIII). The Committee recommended marketing authorisation for rFXIII for once-monthly replacement therapy in patients from the age of six years with congenital factor XIII A-subunit deficiency. Congenital factor XIII deficiency is a rare bleeding disorder with potentially life-threatening consequences, including CNS bleeding, if not treated. It is estimated that about 300 patients in Europe and approximately 900 globally are diagnosed with the disease. A decision from the EMA is expected in the next three months.