Janssen seeks US FDA approval of investigational single tablet combo therapy of macitentan & tadalafil to treat pulmonary arterial hypertension

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a New Drug Application (NDA) to the US 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 haemodynamics (blood flow through pulmonary blood vessels) versus macitentan and tadalafil monotherapies in this PAH patient population.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!