Janssen seeks EMA approval for hypertension combination therapy


Janssen has submitted a marketing authorisation application to the European Medicines Agency (EMA) seeking approval of single tablet combination therapy (STCT) of macitentan and tadalafil for pulmonary arterial hypertension (PAH).

The single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) is intended for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients of WHO functional class (FC) II-III.

The application is based on data from the Phase III A DUE study, which demonstrated that the M/T STCT significantly improved pulmonary haemodynamics versus macitentan and tadalafil monotherapies in patients with PAH.

Recently updated European Society of Cardiology/European Respiratory Society (ESC/ERS) pulmonary hypertension (PH) guidelines have strengthened recommendations on 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 targets two or more PAH-specific pathways is available for these patients in Europe.

Tamara Werner-Kiechle, EMEA Therapeutic Area Lead Neuroscience and Pulmonary Hypertension, Janssen-Cilag GmbH, said: “A single tablet combination could be an important new option for people living with PAH with the potential to enhance convenience and help improve adherence and outcomes. We look forward to working with the EMA to bring this combination therapy to those in need of new options, as soon as possible.”

The application to the EMA follows a New Drug Application submitted to the US Food and Drug Administration (FDA) in May 2023 seeking approval of single tablet combination therapy of macitentan and tadalafil for the treatment of patients with PAH.

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