Johnson & Johnson Submits NDA in China for Macitentan/Tadalafil Fixed-Dose Combination Tablet for Pulmonary Arterial Hypertension

Intelligent Finance APP learned that the CDE website showed Johnson & Johnson (JNJ.US) innovative compound drug "Macitentan Tadalafil Tablets" has applied for marketing in China, for the treatment of pulmonary arterial hypertension (PAH). PAH is a rare, progressive, and life-threatening vascular disease, characterized by the contraction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation, eventually leading to right heart failure. Currently, several drugs have been approved for the treatment of PAH, including prostaglandin I2 (PGI2) analogs, PGI2 receptor agonists, ERA, PDE5 inhibitors, and nitric oxide (NO).

It is reported that Macitentan Tadalafil Tablets (US brand name: Opsynvi) is an innovative single-tablet combination therapy obtained by Johnson & Johnson through the acquisition of Actelion Pharmaceuticals. It consists of macitentan, a dual endothelin A receptor/endothelin B receptor (ETA/ETB) antagonist, and tadalafil, a phosphodiesterase-5 (PDE5) inhibitor. The drug was first approved for marketing in Canada in 2021 and received approval in the United States and the European Union in 2024 for the long-term treatment of adult patients with pulmonary arterial hypertension (PAH) classified as World Health Organization (WHO) functional class (FC) II-III.