“The ESC/ERS guidelines recommend double and triple combination therapy which means that PAH patients may increasingly face more complex treatment regimens, with some taking many pills each day to manage their condition and any potential comorbidities,' said Tamara Werner-Kiechle, M.D., EMEA Therapeutic Area Lead Neuroscience and Pulmonary Hypertension, Janssen-Cilag GmbH. “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.” 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.

PAH is a rare, progressive and life-threatening disease characterised by the constriction of small pulmonary arteries and elevated blood pressure (hypertension) in the pulmonary circulation that eventually leads to right heart failure. 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. The application is based on data from the Phase 3 A DUE study, which demonstrated that the M/T STCT significantly improved pulmonary haemodynamics (blood flow through pulmonary blood vessels) versus macitentan and tadalafil monotherapies in patients with PAH. The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of a single tablet combination therapy of macitentan 10 mg and tadalafil 40 mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization Group 1) in adult patients of WHO functional class (FC) II-III.

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