LONDON (dpa-AFX) - AstraZeneca Plc (AZN.L, AZN) said on Tuesday that Selumetinib, sold under the brand name Koselugo, has been approved in Japan to treat the patients of three years or above with plexiform neurofibromas or PNs in neurofibromatosis type 1 or NF1 that includes pain and disfigurement, and PNs which cannot be completely removed by surgery without risk of substantial morbidity.
Selumetinib is the first drug approved in Japan to treat this rare and debilitating genetic condition.
The Japanese Ministry of Health, Labour and Welfare's decision was based on the 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).
The trial showed Koselugo, an oral treatment option, reduced the size of inoperable tumours in children.
Yoshihiro Nishida, Japan Phase I trial investigator said: '.This approval marks a major step forward in addressing the debilitating impact these plexiform neurofibromas have on paediatric patients living with neurofibromatosis type 1 in Japan. Koselugo provides a suitable intervention to treat symptomatic plexiform neurofibromas, which may improve long-term patient activities of daily living and quality of life.'
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