Pulmonary arterial hypertension (PAH), a rare and chronic disorder characterized by high blood pressure (hypertension) in the lungs that causes the pulmonary arteries to thicken or harden, most often manifests in women between ages 30 to 60. Characterized by symptoms such as shortness of breath during exertion, chest pain, fatigue, fainting, and swelling in the lower extremities, PAH can greatly impair quality-of-life. As the arteries in the lungs narrow, the heart also has to work harder to push blood through and receive oxygen, weakening the heart muscle.
PAH is treatable, though not curable. However, currently available treatments require multiple pills each day, putting a higher burden on patients. That is, until now.
Approving Opsynvi for PAH
Tristan Manalac reports in BioSpace that the U.S. Food and Drug Administration (FDA) recently approved a new combination therapy pill called Opsynvi for adults living with pulmonary arterial hypertension. It is taken either as a 1omg/20mg or 10mg/40mg pill taken once daily with or without food. Opsynvi, developed by Johnson & Johnson, is described in the prescribing information as:
a combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, indicated for chronic treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients of WHO functional class (FC) II-III.
Functional classes II-III, as described by the WHO, include people who are asymptomatic when resting but symptomatic when performing normal daily activities like walking or climbing stairs, meaning that PAH limits their activity level. Opsynvi can also be used to treat people who are treatment-naive (have not undergone prior treatment) or who have previously been treated with ERA or PDE5 inhibitors.
Opsynvi’s approval comes follow data from the Phase 3 A DUE clinical trial. Within the trial, researchers evaluated Opsynvi compared to either macitentan or tadalafil on their own to understand how effective it was. The study found that Opsynvi significantly improved pulmonary function, addressed pulmonary vascular resistance issues, and increased 6-minute walk distance when compared to the treatments on their own.
