FDA Approves Fixed-Dose Macitentan/Tadalafil Tablets for PAH: Daily Dose

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Last week, we reported on the US Food and Drug Administration (FDA) approval of the single-tablet macitentan and tadalafil combination Opsynvi for the chronic treatment of adults with pulmonary arterial hypertension (PAH; World Health Organization [WHO] Group I) and WHO functional class (FC) II-III.

The approval

The combination oral therapy is indicated for use by individuals with PAH who are treatment naïve or who are already treated with one or both of the combination’s components, the endothelin receptor antagonist [ERA] macitentan and the phosphodiesterase 5 [PDE5] inhibitor tadalafil, or who are currently treated “concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets,” according to the announcement by drugmaker J&J. The 2 agents are typically prescribed together as guideline-directed initial therapy for PAH.

The foundation for the FDA approval is the A DUE study, a double-blind, randomized, active-control parallel group study that compared the efficacy and safety of the fixed dose macitentan and tadalafil combination to each drug as monotherapy in adults with PAH (WHO FC II or III) who were treatment naïve or on stable doses of an ERA or PDE5 inhibitor for at least 3 months. The study’s primary endpoint was the change from baseline in pulmonary vascular resistance (PVR) at week 16. After this treatment period, participants were transitioned to the study’s open-label period for 24 months.

Results showed change in PVR with the macitentan and tadalafil single-tablet combination was significantly greater versus macitentan (treatment effect, 29%; 95% CL, -18% to -39%; P < .0001). PVR change with the combination was also significantly greater versus tadalafil (treatment effect, 28%; 95% CL, -20% to -36%; P < .0001).

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