FDA recently approved Opsynvi

FDA recently approved Opsynvi

The FDA recently approved Opsynvi, developed by Johnson & Johnson, for treating pulmonary arterial hypertension (PAH) in adults, marking a significant advancement in PAH management. Opsynvi combines macitentan and tadalafil into a single, once-daily tablet, offering a convenient and effective treatment option.

Macitentan, an endothelin receptor antagonist, and tadalafil, a phosphodiesterase 5 inhibitor, work synergistically to improve blood flow and reduce pulmonary artery pressure. Clinical trials demonstrated Opsynvi’s efficacy in improving exercise capacity, reducing clinical worsening, and enhancing quality of life in PAH patients compared to standard therapy alone. It is indicated for both treatment-naïve patients and those already receiving PAH therapy.

Opsynvi is available in two strengths and administered orally once daily, but it is contraindicated in pregnant women and those hypersensitive to its components. Johnson & Johnson is seeking EMA approval for Opsynvi in the European Union, offering patients a promising new option for managing PAH and improving their quality of life.

The press release from Johnson&Johnson can be found here.

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