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Danish pharmaceutical company Ascendis Pharma A/S (ASND) announced that the United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for YORVIPATH (palopegteriparatide; developed as TransCon PTH) in Great Britain as a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidismThe MHRA has also granted YORVIPATH orphan drug status.
丹麦制药公司Ascendis Pharma A/S(ASND)宣布,英国药品和保健品管理局(MHRA)已批准YORVIPATH(palopegteriparatide;开发为TransCon PTH)在英国上市,作为甲状旁腺激素(PTH)替代疗法,用于治疗成人慢性甲状旁腺功能减退症。MHRA还授予YORVIPATH孤儿药地位。
YORVIPATH is a prodrug of parathyroid hormone (PTH 1-34) administered once daily.MHRA approval of YORVIPATH is based on the same dossier submitted with Ascendis Pharma's Marketing Authorisation Application to the European Medicines Agency, which led to European Commission authorization of YORVIPATH in the European Union in November 2023..
YORVIPATH是甲状旁腺激素(PTH 1-34)的前药,每天服用一次。MHRA对YORVIPATH的批准基于Ascendis Pharma向欧洲药品管理局提交的上市许可申请中提交的相同档案,该申请导致欧盟委员会于2023年11月在欧盟批准YORVIPATH。。
The orphan status provides 10 years of market exclusivity in Great Britain with respect to similar medicinal products in the approved orphan indication of chronic adult hypoparathyroidism.TransCon PTH is also in development for the treatment of adults with chronic hypoparathyroidism in the United States, Japan, and other countries.
孤儿身份为英国批准的慢性成人甲状旁腺功能减退症孤儿适应症中的类似药品提供了10年的市场排他性。TransCon PTH在美国,日本和其他国家也正在开发用于治疗成人慢性甲状旁腺功能减退症。
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