Orphan drug status for gilteritinib in Japan

22 March 2018

Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted Orphan Drug designation to gilteritinib for the treatment of FLT3mut+ acute myeloid leukemia (AML), the drug’s prospective indication.

The positive news for the drug’s developer, Astellas Pharma (TYO: 4503), saw the firm’s shares rise 2.04% to 1,622 yen in Tokyo trading today. The US Food and Drug Administration has already granted fast track-designated gilteritinib.

Gilteritinib is at the vanguard of the company’s increasing investments in the oncology space, a company executive recently told The Pharma Letter, noting that Astellas believes that it is likely to be the ‘best in class’ agent. Having gained US approval a year ago and EU approval in September, Novartis has first mover advantage in the FLT3-targeting AML with its Rydapt (midostaurin).

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