Janssen seeks FDA approval of new drug application to treat PAH

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The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a new drug application to the U.S. Food and Drug Administration (FDA) on May 30, 2023. Janssen seeks approval of the first and only single tablet combination therapy for the long-term treatment of pulmonary arterial hypertension (PAH). The pill combines 10mg of macitentan and 40mg of tadalafil (M/T STCT), which are current individual therapies. 

“People with PAH are often prescribed numerous medicines to manage their condition, so the potential to offer a single tablet combination of two guideline-recommended therapies could not only decrease pill burden but may also help improve the patient treatment experience and clinical outcomes," said James F. List, MD, PhD, Global Therapeutic Area Head, Janssen Research & Development, LLC.

Janssen’s application for approval is based on late-breaking, positive data from its phase 3 A DUE study, which enrolled 187 adult patients across 148 sites in 19 countries. The double-blind, randomized, active-controlled, multicenter, adaptive parallel-group study met its primary endpoint and validated its comparison of the safety and efficacy of M/T STCT versus monotherapies in the population of PAH patients. 

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