Otsuka Pharmaceutical’s PDE4 inhibitor Difamilast files for approval in China

On September 25, the website of China's Center for Drug Evaluation (CDE) showed that Otsuka Pharmaceutical's Class 5.1 new drug Difamilast ointment has submitted a marketing application. Based on the clinical trial progress of the drug, the intended indication for this application is presumed to be atopic dermatitis.

Difamilast is a non-steroidal, topical anti-inflammatory phosphodiesterase-4 (PDE4) inhibitor discovered by Otsuka Pharmaceutical. It was first approved in Japan in September 2021 for the treatment of atopic dermatitis. The drug received clinical trial approval in China for the first time in 2022 and submitted its marketing application on September 25.

In February 2016, Otsuka granted Medimetriks the rights to develop, commercialize, and manufacture Difamilast in the U.S. market, and development efforts there are currently underway.

According to media reports, there are currently two PDE4 inhibitors approved for marketing in China: Apremilast and Crisaborole Ointment. In addition to Difamilast, Hemei Pharma's Mufemilast (Hemay005) is also under review for marketing approval.