Opsynvi FDA Approval History
Last updated by Judith Stewart, BPharm on April 2, 2024.
FDA Approved: Yes (First approved March 22, 2024)
Brand name: Opsynvi
Generic name: macitentan and tadalafil
Dosage form: Tablets
Company: Actelion Pharmaceuticals US, Inc.
Treatment for: Pulmonary Arterial Hypertension
Opsynvi (macitentan and tadalafil) is an endothelin receptor antagonist (ERA) and phosphodiesterase 5 (PDE5) inhibitor combination for the treatment of pulmonary arterial hypertension.
- Opsynvi is indicated for the chronic treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients of WHO functional class (FC) II-III.
- PAH is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation that eventually leads to right heart failure.
- Opsynvi contains a combination of two previously approved drugs. Macitentan was first approved under the brand name Opsumit, and tadalafil was first approved under the brand name Adcirca as monotherapies for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1).
- Macitentan works to reduce the risk of clinical worsening events and hospitalization, and tadalafil works to improve exercise ability.
- FDA approval of Opsynvi was based on the results from the pivotal Phase 3 A DUE study, in which Opsynvi demonstrated greater reduction in Pulmonary Vascular Resistance (PVR) after 16 weeks versus macitentan or tadalafil monotherapy.
- Opsynvi tablets are administered orally, once daily, with or without food.
- The Opsynvi product label carries a Boxed Warning due to the risk of embryo-fetal toxicity. For all female patients, Opsynvi is available only through a restricted program called the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS).
- Warnings and precautions associated with Opsynvi include hepatotoxicity, hypotension, decreased hemoglobin, worsening pulmonary veno-occlusive disease, loss of vision, hearing impairment, fluid retention, decreased sperm count, and prolonged erection.
- Common adverse reactions include edema/fluid retention, anemia, and headache/migraine.
Development timeline for Opsynvi
Further information
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