Combination Revelation

Johnson & Johnson recently announced the FDA approval of its combinatorial drug Opsynvi (macitentan and tadalafil). Select medicines in the J&J portfolio have been studied in outcome-driven trials in participants representative of real-world patients in terms of pulmonary arterial hypertension (PAH) sub-types, common comorbidities, newly diagnosed patients, and those further along in their treatment journey; these trials have proven to delay disease progression and reduce hospitalizations. A rare and difficult-to-diagnose disease, PAH affects between 15 and 50 people per million in the US and Europe (1), with higher incidence in women. PAH may be idiopathic, heritable, induced by drugs or toxins, or associated with other diseases, including congenital heart disease or portal hypertension. There is no known cure, but developers at Johnson & Johnson are determined to improve its management. 

Early diagnosis and specialized referral is currently key to successful treatments due to the inherent complexities and progressive nature of PAH, but researchers at J&J have developed a product to simplify the treatment process. I spoke to Sean Studer, Vice President of Medical Affairs, at Johnson & Johnson, to find out more about the challenges associated with and potential solutions to PAH. “People with PAH often live with the burden of taking many pills every day,” he said. “Clinical guidelines recommend treating patients with initial and sequential dual-combination therapy, regardless of risk at initial diagnosis and follow-up. Historically, this required patients to take multiple pills because no single-tablet combination therapy targeting two or more pathways was available.” 

As a single-tablet combination of an ERA and a PDE5 inhibitor, J&J’s Opsynvi has been developed to simplify prescriptions and potential prior authorizations. As the administration of macitentan and tadalafil are commonly prescribed together for initial therapy for PAH, the introduction of a single tablet with both drugs could help clinicians bridge the gap between guidelines and everyday practice, while potentially optimizing disease management.

FDA approval of Opsynvi was based on the results from the phase III A DUE study, which met its co-primary endpoints of “demonstrating significant pulmonary hemodynamic improvement.” Published in the Journal of the American College of Cardiology (2), the study demonstrated that macitentan and tadalafil significantly improved blood flow through pulmonary blood vessels (pulmonary hemodynamics), versus macitentan and tadalafil monotherapies in a particular PAH patient population. 

“At Johnson & Johnson, we are building on more than 20 years of data in the PAH space and working to transform PAH into a long-term manageable condition.” Studer added. “We remain steadfast in our commitment to pulmonary hypertension, and work to drive innovation and provide support to address unmet needs.”