Chugai files for Japanese approval of M8010

26 May 2015

Japanese drug major Chugai Pharmaceutical (TYO: 4519) has submitted a New Drug Application to Japan’s Ministry of Health, Labor and Welfare for a combination topical drug preparation of maxacalcitol and betamethasone butyrate propionate (Development Code: M8010).

Shares of Chugai, which is majority (62%)-owned by Swiss pharma giant Roche (ROG: SIX), rose 1.05% to 3,850 yen in Tokyo trading on Monday.

M8010 has been co-developed with Maruho Co, which is involved in the R&D, manufacturing and commercialization of dermatological products, for the indication of psoriasis vulgaris. M8010 is a topical preparation combining maxacalcitol, an active vitamin D3 derivative created by Chugai, and the corticosteroid betamethasone butyrate propionate. Both drugs are indicated for psoriasis vulgaris and are used together to treat the disease in medical practice.

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