BRIEF—Japan's MHLW approves vibegron for overactive bladder

24 September 2018

Kyorin Pharmaceutical has received marketing approval from Japan's Ministry of Health, Labor and Welfare for vibegron for the treatment of adults with overactive bladder (OAB) in Japan.

Kyorin licensed vibegron for Japan from Merck & Coin 2014, and later expanded the license to include certain other Asian countries in 2017.

Urovant Sciences licensed rights to vibegron for the USA and the rest of the world from Merck, Sharp & Dohme, a subsidiary of Merck & Co in 2017 and subsequently entered into a collaboration agreement with Kyorin later that year.

Under the collaboration agreement, Urovant and Kyorin share information related to the development of vibegron, including clinical trial and non-clinical study data.

Urovant initiated its international pivotal Phase III clinical trial of vibegron in adults with OAB earlier this year.

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