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GSK PLC on Monday said it has landed an approval in Japan and also highlighted regulatory progress in the EU. The Brentford, London-based pharmaceutical company said that its medicine Omjjara has been approved by Japan’s Ministry of Health, Labour & Welfare for use in both newly diagnosed or previously treated myelofibrosis patients. ‘Myelofibrosis has a heavy disease burden, with symptomatic patients experiencing spleen enlargement, fatigue, night sweats and bone pain, along with anaemia which can lead to treatment discontinuation and dependence on regular blood transfusions. With the approval of Omjjara, myelofibrosis patients in Japan will have a new treatment option for this complex blood cancer,’ said Nina Mojas, senior vice president, Oncology Global Product Strategy. GSK explained this is the ‘fourth major regulatory approval’ for the drug in the myelofibrosis space, following backing in the UK, US and the EU. Also in the EU, it announced Monday its Jemperli plus chemotherapy treatment has been accepted for review by the European Medicines Agency to expand its use. If the application is approved, it will allow the drug combo to be used in all patients with primary advanced or recurrent endometrial cancer. ‘The EMA’s Committee for Medicinal Products for Human Use will begin the formal review process to make a recommendation to the European Commission, with approval expected in H1 2025,’ GSK added. GSK shares were up 0.6% at 1,608.00 pence each on Monday morning in London. Copyright 2024 Alliance News Ltd. All Rights Reserved.
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