智通财经APP获悉,CDE网站显示,强生(JNJ.US)的创新复方药物“马昔腾坦他达拉非片”在国内申报上市,用于治疗肺动脉高压(PAH)。PAH是一种罕见的进行性且危及生命的血管疾病,其特征为小肺动脉收缩和肺循环血压升高,最终导致右心衰竭。目前已有多款药物获批用于治疗PAH,包括前列腺素I2(PGI2)类似物、PGI2受体激动剂、ERA、PDE5抑制剂和一氧化氮(NO)。
据悉,马昔腾坦他达拉非片(美国商品名:Opsynvi)是强生收购Actelion Pharmaceuticals获得的一款创新单片复方制剂,由内皮素A受体/内皮素B受体(ETA/ETB)双重拮抗剂马昔腾坦(macitentan)与磷酸二酯酶5(PDE5)抑制剂他达拉非(tadalafil)组成。该药物于2021年首次在加拿大获批上市,并于2024年在美国和欧盟获批上市,用于世界卫生组织(WHO)功能分级(FC)为II-III级的PAH成人患者的长期治疗。
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