Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that an application has been submitted to the Pharmaceuticals and Medical Devices Agency in Japan to seek manufacturing and marketing approval for difamilast (OPA-15406) in patients with atopic dermatitis.

Difamilast is a topical atopic dermatitis drug candidate discovered by Otsuka that has phosphodiesterase 4 (PDE4) inhibitory activity. PDE4 inhibitors are believed to improve the symptoms of atopic dermatitis through suppression of the production of chemical mediators such as pro-inflammatory cytokines and through other anti-inflammatory effects.

The number of patients in Japan with atopic dermatitis is about 4.34 million, a number which increases year by year. (Source: Datamonitor Healthcare, Treatment: Atopic Dermatitis 2017 | Informa)

Otsuka entered into a licensing agreement with Medimetriks, Inc. in 2016 which granted Medimetriks development, marketing, and manufacturing rights for difamilast in the United States.