Orfadin® (nitisinone) receives positive opinion from CHMP for treatment of AKU
Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Orfadin® (nitisinone) for the treatment of adult patients with alkaptonuria (AKU), the first described human genetic disease. The opinion is now referred to the European Commission for a decision. AKU is a serious, multifaceted, debilitating and slowly progressive disease affecting approximately 1 in every 250 000 to 1 million people. Also known as Black Bone Disease or