Torrent's Generics Macitentan Receives Approval in US
If approved, Yuvanci® would become the only single tablet combination for treatment for patients with PAH Johnson & Johnson’s comprehensive PAH portfolio has the potential to cover all...
FDA approves Johnson & Johnson`s combo pill Opsynvi for PAH
FDA Approves OPSYNVI® (macitentan and tadalafil) for Patients with PAH
Apotex`s Generic Macitentan Receives Approval in the U.S.
This is the first and only single tablet combination therapy to be submitted for review in Europe for this rare, progressive disease If approved, Janssen™s comprehensive PAH portfolio has the...
RARITAN, N.J., May 30, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today 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.1 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.
With many pulmonary arterial hypertension (PAH) patients already taking Johnson & Johnson’s Opsumit (macitentan) or United Therapeutics' Adcirca (tadalafil), J&J has been pursuing a potential combination of the two therapies for several years.
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)
RHODES' Generic Macitentan Receives Approval in the U.S.