The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a new drug application (NDA) for its investigational single-tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) to the US Food and Drug Administration (FDA), to treat pulmonary arterial hypertension (PAH).
The company is seeking approval for the combination therapy for the long-term treatment of PAH in adult patients with World Health Organisation functional class II-III.
Go deeper with GlobalData
Tadalafil is a phosphodiesterase type 5 inhibitor intended to treat PAH (WHO Group I) to enhance exercise ability, while Opsumit (macitentan) is a prescription medicine.
Janssen has submitted the NDA based on positive data from the Phase III A DUE trial, which achieved its primary endpoint.
The randomised, multi-centre, double-blind, active-controlled and adaptive parallel group trial compared the safety and efficacy of investigational M/T STCT against macitentan and tadalafil monotherapies in PAH patients.
It demonstrated that the combination therapy had a significant positive impact on pulmonary haemodynamics compared to the individual treatments of macitentan and tadalafil in patients with PAH.
Janssen research and development global therapeutic area head Dr James List stated: “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.
“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.”
