J&J Wins FDA Nod for Pulmonary Arterial Hypertension Combo Pill
25 Mar 2024
Phase 3Clinical ResultDrug Approval
Pictured: Johnson & Johnson's office in Spain/iStock, BrasilNut1
The FDA on Friday signed off on Johnson & Johnson’s single-tablet combination therapy of macitentan and tadalafil for the treatment of pulmonary arterial hypertension (PAH) in adults. The drug will be sold under the brand name Opsynvi.
The combo pill is indicated for chronic use in pulmonary arterial hypertension (PAH) patients falling under the World Health Organization’s functional classes II to III. These classes include patients who may have no symptoms at rest but experience shortness of breath or discomfort during normal activities such as climbing stairs or running errands. These patients are also limited in their daily activities due to PAH symptoms.
James List, global therapeutic area head at J&J, in a statement said that the company is “thrilled” about the FDA approval, adding that Opsynvi has “the potential to optimize disease management and fulfill a significant unmet need” for PAH patients who “often live with the burden of taking many pills each day.”
Opsynvi can also be used in patients who are treatment-naïve or who had already been exposed to prior endothelin receptor antagonist (ERA) and phosphodiesterase 5 (PDE5) inhibitorsphosphodiesterase 5 (PDE5) inhibitors. Its label carries a boxed warning for embryo-fetal toxicity. For women, Opsynvi is only available through a risk evaluation and management strategy program. Designed to be orally available, Opsynvi is a combination of two drugs: the ERA macitentan and the PDE5 inhibitor tadalafil. These medicines work synergistically—macitentan cuts the risk of clinical worsening and hospitalization, while tadalafil boosts patients’ exercise capacity.
J&J backed Opsynvi with data from the Phase III A DUE study, a double-blinded, randomized, parallel-group and active-controlled trial enrolling 187 PAH patients. The trial compared Opsynvi to macitentan and tadalafil monotherapy and assessed its efficacy primarily through the change in pulmonary vascular resistance (PVR) at 16 weeks.
The company presented data from A DUE in March 2023 at the American College of Cardiology’s 72nd Annual Scientific Session & Expo. Compared with macitentan and tadalafil monotherapy, Opsynvi had treatment effects of 29% and 28%, respectively, which were statistically significant with p-values less than 0.0001.
At the time, J&J noted that Opsynvi treatment also resulted in a “clinically relevant improvement” in six-minute walk distance versus monotherapy with either macitentan or tadalafil.
With Opsynvi’s approval, J&J’s PAH portfolio now targets “all three foundational and guideline-recommended pathways,” according to the company. Uptravi (selexipag) addresses the prostacyclin pathway, Opsumit (macitentan) works via the endothelin cascade and now Opsynvi targets the nitric oxide pathway.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
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