At this year’s American College of Cardiology (ACC) Scientific Session, positive results were presented from Johnson & Johnson’s A DUE analyses of Opsynvi (macitentan and tadalafil), providing insight into the drug’s ability to reduce pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension (PAH). Specifically, the trial set out to evaluate efficacy and safety of a fixed-dose combination of 10mg of macitentan and 40mg of tadalafil versus either drug as a monotherapy in treating PAH patients. The positive data from the A DUE study will help support the use of Opsynvi, as PAH patients would need to take a reduced number of pills daily, therefore improving overall quality of life.
Over the past decade, the PAH disease space has consisted mainly of reformulations of existing PAH drugs and the repurposing of known drugs from other disease markets. Existing players in this space have focused on improving treatment delivery options. The A DUE study, which included 187 PAH patients with functional classes II and III, found that patients experienced a 29% reduction in pulmonary vascular resistance with Opsynvi versus those on macitentan alone. Additionally, patients experienced a 28% reduction in pulmonary vascular resistance with Opsynvi versus tadalafil alone. Additionally, the study found improvement in six-minute walking distance with Opsynvi versus monotherapies. Regarding overall safety, no new safety observations were found.
The PAH market is expected to grow at a compound annual growth rate of 5.0%, reaching $7.5bn in 2029, across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan) according to GlobalData’s Pulmonary Arterial Hypertension: Seven-Market Drug Forecast and Market Analysis – Update report. Major driving factors of this growth include the launch of disease-modifying therapies, drug reformulations and increased uptake of combination therapy. The currently available drugs work to slow the disease progression, but there is no marketed drug that addresses the underlying disease mechanism and is targeted at curing patients.
Current therapies act on three main pathways: nitric oxide, endothelin, and prostacyclin. GlobalData believes that it will be easier for new drug entrants to capture market share if they target a novel fourth pathway. For example, most key opinion leaders (KOLs) interviewed by GlobalData expressed strongly positive opinions about Merck’s sotatercept. Sotatercept prevents blood vessel remodeling by restoring vascular homeostasis between cell proliferation and apoptosis by signaling via the bone morphogenetic protein receptor type 2.