Janssen asks FDA to approve macitentan, tadalafil combo tablet

Both drugs already approved for pulmonary arterial hypertension treatment

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Janssen Pharmaceuticals has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of a combination tablet containing both macitentan and tadalafil as a treatment for pulmonary arterial hypertension (PAH).

“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,” James List, MD, PhD, global therapeutic area head at Janssen Research & Development, who oversees Janssen’s pulmonary hypertension program, said in a company press 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,” List said.

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Macitentan is the active agent in Opsumit, an approved PAH treatment sold by Janssen. It works by blocking the activity of proteins called endothelin receptors, which prompts blood vessels to relax and widen, thereby lowering blood pressure.

Tadalafil also is approved on its own as a treatment for PAH; it is sold under the brand name Adcirca by United Therapeutics, Tadliq by CMT Pharma, and the generic Alyq by Teva Pharmaceuticals. This medication also works to lower blood pressure by prompting blood vessels to widen and relax, though it acts on a different molecular target called phosphodiesterase-5.

These two distinct classes of therapies are often combined; a recent study funded by Janssen indicated that the use of combination therapy among PAH patients has increased in the last decade. Janssen’s new tablet therapy, referred to as M/T STCT, contains a combination of 10 mg macitentan and 40 mg tadalafil. The company expects the combination tablet may help reduce the burden of treatment on patients by decreasing the number of pills needed to be taken in a day.

Janssen’s application to the FDA is based on data from the Phase 3 clinical trial A DUE (NCT03904693), sponsored by Actelion, part of the Janssen Pharmaceutical Companies of Johnson & Johnson. The study included 187 adults with PAH who were randomly assigned to receive the M/T STCT combination, or either macitentan or tadalafil on their own.

Results from the trial showed the combination therapy outperformed either individual medication at improving pulmonary blood flow and patients’ exercise capacity. The safety profile of the combination was comparable to that of its individual components.

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