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.
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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.
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By GlobalDataJanssen 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.”
