Flurry of Japanese drug approvals

In a busy day for the Japanese regulator, the Japanese Ministry of Health, Labor and Welfare (MHLW) has cleared three new medicines from European drugmakers for marketing in the country.

First up is UK pharma major AstraZeneca’s (LSE: AZN) Koselugo (selumetinib) for the treatment of pediatric patients three years of age and older with plexiform neurofibromas (PNs) in neurofibromatosis type 1 (NF1) with clinical symptoms, such as pain and disfigurement, and PNs which cannot be completely removed by surgery without risk of substantial morbidity.1

The approval bis based on positive results from the SPRINT Stratum 1 Phase II trial sponsored by the National Institutes of Health's National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP).