BRIEF—Mitsubishi Tanabe files for valbenazine approval in Japan

Japan’s Mitsubishi Tanabe Pharma has filed a new drug application (NDA) in Japan for the VMAT2 inhibitor valbenazine to treat tardive dyskinesia.

The drug, approved in the USA in 2017 under the name Ingrezza, was developed by the US biotech Neurocrine.

At that time, it became the first drug cleared by the Food and Drug Administration for the treatment of adults with tardive dyskinesia (TD).

Mitsubishi Tanabe bought the Asia rights from Neurocrine in 2015, and filed the NDAs in Singapore, Thailand, South Korea and Malaysia in 2020.