EMA to review generic version of Sobi's Orfadin
Swiss pharmaceutical firm Dipharma has announced that the European Medicines Agency has validated its Marketing Authorization application for Disanit (nitisinone).
The drug is a generic version of Swedish Orphan Biovitrum’s (STO: SOBI) Orfadin, which is indicated for the treatment of hereditary tyrosinemia type 1 (HT-1), a rare condition that can cause serious liver problems including liver cancer.
Unlike its reference product, Disanit capsules can safely be stored at room temperature, without the need for refrigeration.
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