Filing of New Drug Application for M8010 topical treatment for psoriasis

[Fred]

Chugai Pharmaceutical Co has submitted a new drug application for M8010 a topical combination of maxacalcitol (an active vitamin D3 derivative) and corticosteroid betamethasone butyrate propionate for the treatment of psoriasis.

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Chugai Pharmaceutical Co., Ltd. [Head Office: Chuo-ku, Tokyo; Chairman & CEO: Osamu Nagayama] (hereafter “Chugai”) announced today that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare for a combination topical drug preparation of maxacalcitol and betamethasone butyrate propionate (Development Code: M8010). M8010 has been co-developed with Maruho Co., Ltd. [Head Office: Kita-ku, Osaka; President and CEO: Koichi Takagi] (hereafter “Maruho”) 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.

A Japanese phase III clinical study was conducted to evaluate a once-daily topical application of M8010 against maxacalcitol ointment monotherapy (twice daily inunction) and betamethasone butyrate propionate ointment monotherapy (once daily application). The result showed superiority over both monotherapies in terms of primary endpoint (total score of PSI at four weeks), and secondary endpoint (rate of reduction of mPASI at four weeks). As for safety, rhinopharyngitis and reduction of blood cortisol were observed as major adverse events during the study. However, these were mild and no major difference was observed in the rate of occurrence compared with both monotherapies, so safety of M8010 was similar to that of both drugs.

The collaboration between Chugai and Maruho started with the launch of Oxarol® Ointment, a product of maxacalcitol in 2001. Both companies will make efforts to obtain early approval and make sure that M8010 can be delivered to patients and healthcare professionals as soon as possible. Maruho will be responsible for providing information and marketing activities after an approval is obtained, the same responsibilities Maruho has for Oxarol® Ointment and Lotion, which are already on the market.

Source: chugai-pharm.co.jp

[jiml]

Good news a new topical treatment which is hopefully superior to other topicals so should be a good alternative to preparations already available I hope it becomes available soon the more alternative treatments available to sufferers the better