欧盟批准真性红细胞增多症(PV)治疗药物

2019-02-22 不详 MedSci原创

PharmaEssentia和AOP Orphan的Besremi(Ropeginterferon Alfa-2b)药物获得欧盟批准用于治疗真性红细胞增多症(PV)。

PharmaEssentia和AOP Orphan的Besremi(Ropeginterferon Alfa-2b)药物获得欧盟批准用于治疗真性红细胞增多症(PV)。

欧盟委员会(EC)昨日宣布批准Besremi用于治疗脾不肿大的PV。欧洲的批准使得Besremi成为第一个也是唯一一个获批的PV治疗药物。

PV是起源于造血干细胞血液肿瘤,可引起红细胞、白细胞和血小板的缓慢增加。该疾病的进展会导致血管并发症,如血栓的形成,也有可能转变为继发性骨髓纤维化或白血病

PharmaEssentia首席执行官Kochung Lin博士说:"PV患者在疾病早期需要得到有效的治疗,否则疾病的持续进展将引起严重的血管并发症。很开心可以为PV患者提供新的治疗药物。"

Ropeginterferon alfa-2b是一种新型长效的单一异构体单聚乙二醇化脯氨酸干扰素(ATC L03AB15),只需2周注射一次,或在长期维持期间每4周注射一次。Ropeginterferon alfa-2b治疗PV在欧盟、瑞士和美国都已获得孤儿药认证。

欧盟委员会的批准适用于所有28个欧盟成员国以及冰岛、挪威和列支敦士登。

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