(News Bulletin 247) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that it has applied for a Marketing Authorization (MAA) from the European Medicines Agency (EMA) seeking approval of a macitentan 10 mg and tadalafil 40 mg single tablet combination therapy (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH) in certain adult patients.
The application is based on data from the Phase 3 A DUE study, which demonstrated that M/T STCT significantly improved pulmonary hemodynamics, compared to macitentan and tadalafil monotherapies in patients with PAH.
PAH is a rare, progressive and life-threatening disease characterized by the constriction of small pulmonary arteries and high blood pressure (hypertension) in the pulmonary circulation which ultimately leads to right heart failure.
The EMA submission follows a New Drug Application submitted to the U.S. Food and Drug Administration (FDA) in May 2023 seeking approval for a single-tablet combination treatment of macitentan and tadalafil for the treatment of patients with PAH.
Copyright (c) 2023 News Bulletin 247. All rights reserved.
I have over 8 years of experience working in the news industry. I have worked as a reporter, editor, and now managing editor at 247 News Agency. I am responsible for the day-to-day operations of the news website and overseeing all of the content that is published. I also write a column for the website, covering mostly market news.
