Press Release

Kaken Submits a New Drug Application for “BBI-4000” for Primary Axillary HyperhidrosisJanuary 14, 2020

Tokyo, January 10, 2020 – Kaken Pharmaceutical Co., Ltd. (“Kaken”) announced that it has submitted a new drug application for approval of manufacturing and marketing for BBI-4000 (generic name: sofpironium bromide) in Japan for primary axillary hyperhidrosis.

 

BBI-4000 is a new molecular entity that belongs to a class of drugs called “anticholinergics,” which exert their effect by blocking the action of acetylcholine, a molecule that transmits signals within the nervous system that are responsible for a range of bodily functions, including the activation of sweat glands.

 

Kaken acquired the rights to the exclusive development, manufacture, and marketing in Japan and certain other Asian countries from Brickell Biotech,Inc., based in Boulder, Colorado, USA and has developed as a topical drug.

 

The application for BBI-4000 in Japan involves the data of the Phase 3 study, targeting patients with primary axillary hyperhidrosis, that have been proven sufficiently efficacy and safety. Upon approval of BBI-4000, Kaken Pharmaceutical seeks to contribute greatly to the treatment of primary axillary hyperhidrosis by providing new treatment option for it.

 

 

About Primary Axillary Hyperhidrosis

A condition that involves heavy sweating on the armpits caused by heat, stress, or occurring without such causes, and interferes with daily life and work.

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