Maruho receives manufacturing and marketing approval in Japan for Topical Scalp Psoriasis Treatment "Comclo® Shampoo 0.05%"
Osaka (Japan), March 30, 2017 - Maruho Co., Ltd ("Maruho", Head Office: Osaka, Japan, President and CEO: Koichi Takagi) announces that today it has received manufacturing and marketing approval in Japan from the Japanese Ministry of Health, Labor and Welfare (MHLW), for topical scalp psoriasis treatment "Comclo® Shampoo 0.05%" (INN: clobetasol propionate) (hereinafter referred to as "the product").
The product is a shampoo-like topical liquid formulation developed by Galderma Pharma S.A. ("Galderma SA", Headquarters: Lausanne, Switzerland, CEO: Stuart Raetzman). Since its first marketing authorization in the US in 2004 for the treatment of scalp psoriasis vulgaris in adults, the product has now been approved in 62 countries around the world under the brand names Clobex Shampoo (US, etc.) and Etrivex Shampoo (UK, etc.) (As of November, 2016).
Maruho and Galderma SA agreed on a license agreement focused on the development and commercialization of the product in Japan, and Maruho has been progressing its development.
Psoriasis vulgaris is a chronic skin disease characterized by redness/irritation and silvery-white scaling of the surface of the skin adhering to sites such as the head, hair line, waist and buttocks. The product is the first prescription shampoo topical formulation approved in Japan that can be applied once a day to the head and rinsed 15 minutes later (short contact therapy). Maruho hopes to increase the treatment options for psoriasis vulgaris of the scalp and contribute to increased medical adherence.
Maruho is confident that the product will contribute to the treatment of patients with psoriasis vulgaris of the scalp.
Product Profile: Comclo® Shampoo 0.05%
INN | Clobetasol propionate |
Formulation/Dose | Topical liquid containing 0.5mg per 1 gram of clobetasol propionate |
Indication | Psoriasis vulgaris of the scalp |
Dosage and Administration |
General administration is to apply once daily to the head when dry, then after 15 minutes lather with hot or cold water and rinse off. |
Approval Requirements |
A pharmaceutical risk management plan should be properly designed and implemented |