Medimetriks Announces that Otsuka has Submitted MM36 (difamilast) New Drug Application for Approval in Japan
FAIRFIELD, N.J., Sept. 29, 2020 /PRNewswire/ -- Medimetriks Pharmaceuticals, Inc. today announced that Otsuka Pharmaceuticals Co. Ltd., submitted an application for approval of MM36 (difamilast) to the Japanese regulatory authorities. Positive MM36 results in two Phase 3 Japanese clinical trials in adult and pediatric patients with mild to moderate atopic dermatitis (AD) were previously announced.
Please find below the Otsuka Pharmaceuticals press release:
"Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that a new drug 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."
"We are pleased that Otsuka has achieved this significant milestone in the development of MM36 for the Japanese market," said Bradley Glassman, Chairman and Chief Executive Officer of Medimetriks. "Given the positive outcome of our recent U.S. FDA Type C meeting, Medimetriks is preparing to begin one, final Phase 3 Pivotal Trial in the U.S. MM36 has demonstrated potential class-leading efficacy, tolerability and itch relief in Phase 2 and Phase 3 studies, and we believe delivers on the vision of helping children and adults suffering from AD achieve better outcomes."
About MM36 (difamilast)
About Atopic Dermatitis
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SOURCE Medimetriks Pharmaceuticals, Inc.