The CDE website shows that Johnson & Johnson (JNJ.US) has submitted an application for the innovative compound drug "Maqitengtan Tadalafil Tablets" to be marketed domestically for the treatment of pulmonary arterial hypertension (PAH).
According to Zhitong Finance APP, the CDE website shows that Johnson & Johnson's innovative combination drug "macitentan and tadalafil tablets" has been filed for domestic上市 to treat pulmonary artery hypertension (PAH). PAH is a rare progressive and life-threatening vascular disease characterized by the constriction of small pulmonary arteries and elevated pulmonary circulatory pressure, ultimately leading to right heart failure. Several drugs have already been approved for the treatment of PAH, including prostaglandin I2 (PGI2) analogs, PGI2 receptor agonists, ERAs, PDE5 inhibitors, and nitric oxide (NO).
It is reported that macitentan and tadalafil tablets (USA Commodity name: Opsynvi) are an innovative single-tablet combination formulation obtained by Johnson & Johnson through the acquisition of Actelion Pharmaceuticals, consisting of the dual antagonist of endothelin A receptor/endothelin B receptor (ETA/ETB) macitentan and the phosphodiesterase 5 (PDE5) inhibitor tadalafil. This drug was first approved for上市 in Canada in 2021 and is set to be approved for上市 in the USA and the EU in 2024 for the long-term treatment of adult patients with PAH classified as WHO function class (FC) II-III.