Japan drug approval recommendations
Japan's First Committee on Drugs of the Council on Drugs and Food Sanitation has recommended approval of four ingredients including an additional indication for Actemura (tocilizumab) from Chugai Pharmaceutical, Roche's Japanese subsidiary and Exjade (deferasirox) from Novartis Pharma, according to informed sources.
Currently Actemura is cleared for the treatment of Castleman's disease. The additional indications include rheumatoid arthritis, poly-articular active juvenile idiopathic arthritis and systemic juvenile idiopathic disease. Exjade is a new ingredient for the treatment of chronic hyperfettemia caused by blood transfusion.
Meanwhile, the Second Committee on Drugs has recommended approval of an additional indication for Herceptin (trastuzumab), marketed by Chugai, as a post-operative adjuvant therapy for breast cancer with HER2 gene over-expression. Presently, the drug's indication in Japan is for the treatment of metastatic breast cancer with HER2 gene over-expression.
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