Janssen seeks approval in Europe for PAH combination therapy tablet
Submission of macitentan-tadalafil treatment follows one in US
Janssen Pharmaceuticals has submitted an application in Europe asking regulatory authorities to approve the company’s combination therapy of macitentan and tadalafil — developed as a single tablet — for pulmonary arterial hypertension (PAH).
The filing comes less than a month after Janssen submitted a similar application seeking approval of the combination tablet in the U.S.
“Today’s submission of the single tablet combination therapy of macitentan and tadalafil to the EMA [European Medicines Agency] marks a significant milestone in our ongoing commitment to transform PAH into a manageable condition and help people living with the condition lead a full life,” James F. List, MD, PhD, global therapeutic area head of Janssen research and development, said in a company press release.
Medicines in combination therapy act on different targets
Both macitentan and tadalafil are individually approved as treatments for PAH: Janssen sells macitentan under the brand name Opsumit, while tadalafil is sold by several developers. Specifically, it’s available as Adcirca from United Therapeutics, as Tadliq by CMT Pharma, and as Alyq from Teva Pharmaceuticals.
These medicines both act to lower blood pressure by prompting blood vessels to relax and widen. However, each acts on distinct molecular targets — macitentan blocks endothelin receptors, whereas tadalafil targets phosphodiesterase-5.
These two therapy classes are often combined in the treatment of PAH. Indeed, such combination therapies have become more common in recent years, according to a Janssen-funded study with results shared earlier this year. The new combination therapy, known as M/T STCT, contains 10 mg macitentan and 40 mg tadalafil in a single tablet.
A single tablet combination could be an important new option for people living with PAH with the potential to enhance convenience and help improve adherence and outcomes.
Janssen’s applications for the combination tablet in the U.S. and Europe are supported by data from the Phase 3 clinical trial A DUE (NCT03904693). The study enrolled 187 adults with PAH, who were randomly assigned to take the M/T STCT combination therapy, or either macitentan or tadalafil alone.
The results showed that the combination therapy was more effective than either individual therapy at improving blood flow in the lungs and boosting patients’ ability to exercise. It’s safety profile was consistent with both individual therapies.
“A single tablet combination could be an important new option for people living with PAH with the potential to enhance convenience and help improve adherence and outcomes,” said Tamara Werner-Kiechle, MD, therapeutic area lead neuroscience and pulmonary hypertension at Janssen-Cilag GmbH.
“We look forward to working with the EMA to bring this combination therapy to those in need of new options, as soon as possible,” Werner-Kiechle said.