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  5. Otsuka Has Filed an Application in Japan for Approval of Difamilast (OPA-15406) as an Atopic Dermatitis Drug

September 28, 2020

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

Otsuka Has Filed an Application in Japan for Approval of Difamilast (OPA-15406) as an Atopic Dermatitis Drug

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.


Information in this news release was current as of the original release date.

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