The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a New Drug Application to the US Food and Drug Administration seeking approval of an investigational 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).
The application is based on positive data from the phase 3 A DUE study, which met its primary endpoint and demonstrated that M/T STCT significantly improved pulmonary hemodynamics versus macitentan and tadalafil monotherapies in adult patients with World Health Organization functional class II-III.
“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,” says James F. List, MD, PhD, global therapeutic area head, whose team oversees a portfolio of programs including pulmonary hypertension at Janssen Research & Development LLC, in a release. “Today’s submission builds on our decades-long commitment to address patient needs and bring forward medicines with the potential to offer an improved standard of PAH care.”
The latest European Society of Cardiology/European Respiratory Society guidelines recommend 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 combines two or more PAH-specific pathways is available for these patients, according to a release from Janssen.
In the phase 3 A DUE study, the safety profile of M/T STCT was consistent with the safety profile of the individual components, macitentan and tadalafil. The open-label arm of the A DUE study is ongoing.