Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH), May 30, 2023

Today, the Janssen Pharmaceutical Companies of Johnson & Johnson have announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). The application seeks approval for an investigational single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) as a long-term treatment option for pulmonary arterial hypertension (PAH). Specifically, it targets adult patients with WHO functional class (FC) II-III, belonging to the World Health Organization (WHO) Group 1. The submission is supported by positive results from the Phase 3 A DUE study, where M/T STCT demonstrated significant improvements in pulmonary hemodynamics, surpassing the effects of macitentan and tadalafil monotherapies within this PAH patient population.

Learn more from the press release on the Janssen website at this link

Photo credit: Danilo Alvesd at Unsplash

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