Posted by Michael Wonder on 27 Jun 2023
Janssen submits marketing authorisation application to the EMA seeking approval of single tablet combination therapy of macitentan and tadalafil for treatment of patients with pulmonary arterial hypertension
26 June 2023 - This is the first and only single tablet combination therapy to be submitted for review in Europe for this rare, progressive disease.
Janssen today announced the submission of a marketing authorisation application to the EMA seeking approval of a single tablet combination therapy of macitentan 10 mg and tadalafil 40 mg for the long-term treatment of pulmonary arterial hypertension (World Health Organization Group 1) in adult patients of WHO functional class II-III.
