Janssen seeks USFDA nod for single tablet combination therapy of Macitentan, Tadalafil for Pulmonary Arterial Hypertension
Raritan: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of an investigational single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients with WHO functional class (FC) II-III.
The application is based on positive data from the Phase 3 A DUE study, which met its primary endpoint and demonstrated that M/T STCT significantly improved pulmonary hemodynamics (blood flow through pulmonary blood vessels) versus macitentan and tadalafil monotherapies in this PAH patient population.
"People with PAH are often prescribed numerous medicines to manage their condition, so the potential to offer a single tablet combination of two guideline-recommended therapies could not only decrease pill burden but may also help improve the patient treatment experience and clinical outcomes," said James F. List, M.D., Ph.D., Global Therapeutic Area Head, whose team oversees a portfolio of programs including Pulmonary Hypertension at Janssen Research & Development, LLC. "The submission builds on our decades-long commitment to address patient needs and bring forward medicines with the potential to offer an improved standard of PAH care."
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. The latest European Society of Cardiology/European Respiratory Society (ESC/ERS) PH guidelines recommend initial double 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.
The NDA is based on late-breaking data from the Phase 3 A DUE study, which met its co-primary endpoints, demonstrating marked pulmonary hemodynamic improvement. The safety profile of M/T STCT was consistent with the safety profile of the individual components, macitentan and tadalafil. The open label arm of the A DUE study is ongoing.
