Late-Breaking Phase 3 A DUE Data Show Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil Significantly Improves Pulmonary Hemodynamics versus Monotherapy in Patients with Pulmonary Arterial Hypertension (PAH)

RARITAN, NJ, March 6, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 3 A DUE study (NCT03904693), which showed an investigational once-daily, single tablet combination therapy, also known as fixed dose combination, of macitentan 10 mg and tadalafil 40 mg (M/T STCT), significantly improved pulmonary hemodynamics (blood flow through pulmonary blood vessels) versus macitentan and tadalafil monotherapies in pulmonary arterial hypertension (PAH) patients with World Health Organization (WHO) functional class (FC) II or III.[1] The data were presented today as a Late-Breaking Clinical Trial presentation during the American College of Cardiology’s 72nd Annual Scientific Session & Expo Together With World Heart Federation’s World Congress of Cardiology.PAH is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation that eventually leads to right heart failure.[2] Recently updated European Society of Cardiology/European Respiratory Society (ESC/ERS) PH guidelines[i] have recommended initial dual combination therapy with macitentan and tadalafil for PAH patients without cardiopulmonary comorbidities. Currently, this requires patients to take multiple pills as no single tablet that combines two or more PAH-specific pathways is available for these patients.[3]“Targeting different pathways in th...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Latest News Source Type: news