FDA approves combination therapy tablet for pulmonary arterial hypertension

The FDA has approved Opsynvi, a once-daily tablet that includes both macitentan and tadalafil, to treat adults with pulmonary arterial hypertension, according to a manufacturer-issued press release.

Opsynvi (Johnson & Johnson) consists of 10 mg macitentan and 40 mg tadalafil and is designated for adults with PAH in WHO functional class I to III, the release states.

As Healio previously reported, the OPTIMA trial found that adults with newly diagnosed PAH started on combination therapy had hemodynamic and functional improvements.

This approval was based, in part, on data from the randomized, active-controlled, multicenter, adaptive parallel-group, phase 3 A DUE study of 187 adults with PAH who either received Opsynvi, tadalafil alone or macitentan alone. Researchers included both treatment-naive patients and patients on a stable dose of an endothelin receptor antagonist (ERA) or a phosphodiesterase 5 (PDE5) inhibitor for a minimum of 3 months, according to a 2023 press release.

Results from the trial showed that from baseline to 16 weeks, the combination tablet lowered pulmonary vascular resistance more than tadalafil or macitentan alone.

With this being the first approved single-tablet combination therapy, patients will no longer need to take multiple pills to meet the 2022 European Society of Cardiology/European Respiratory Society clinical guidelines recommendation: initial combination therapy with an ERA and PDE5 inhibitor.

“As administration of macitentan and tadalafil together are commonly prescribed for initial therapy for PAH, the introduction of a single tablet combining both is promising for clinicians treating patients as it may help bridge the gap between clinical guidelines and everyday clinical practice, while offering a patient-friendly approach to support initial combination therapy and rapid escalation for the appropriate patients,” Kelly Chin, MD, investigator in the A DUE study, professor of internal medicine and director of the pulmonary hypertension program at UT Southwestern Medical Center, said in the release.

Johnson & Johnson noted in the release that there is a risk for embryo-fetal toxicity linked to Opsynvi.

Reference:

• Late-breaking phase 3 A DUE data show investigational single tablet combination therapy of macitentan and tadalafil significantly improves pulmonary hemodynamics vs. monotherapy in patients with pulmonary arterial hypertension (PAH). https://www.jnj.com/media-center/press-releases/late-breaking-phase-3-a-due-data-show-investigational-single-tablet-combination-therapy-of-macitentan-and-tadalafil-significantly-improves-pulmonary-hemodynamics-versus-monotherapy-in-patients-with-pulmonary-arterial-hypertension-pah. Published March 6, 2023. Accessed March 25, 2024.