Janssen submits marketing application to the European Medicines Agency (EMA) for single tablet macitentan and tadalafil (STCT) pulmonary arterial hypertension therapy

On June 26, Janssen filed a marketing authorization application with the European Medicines Agency (EMA) to seek approval for a single tablet combination therapy (STCT) containing macitentan and tadalafil, intended for the treatment of pulmonary arterial hypertension.

Macitentan 10 mg and tadalafil 40 mg STCT is a therapy that combines the Endothelin Receptor Antagonist (ERA) macitentan, and the PDE-5 inhibitor (PDE5i) tadalafil. This is the first and only single tablet combination therapy to be submitted for review in Europe for pulmonary arterial hypertension.

The application to the EMA follows a new drug application submitted to the U.S. Food and Drug Administration (FDA) in May 2023 (see our article at this link)

For further info check the Janssen press release at this link

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