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Adalvo Secures DCP Approval for Macitentan Film-Coated Tablets

Business
06 March 2025

Adalvo announces the DCP approval for Macitentan 10mg film-coated tablets, marking progress in expanding access to essential treatments for pulmonary arterial hypertension (PAH). 

This product is based on the reference brand Opsumit, which generated $1.65 billion globally in 2023, with a 3-year CAGR of +5% (IQVIA). 

Beyond Europe, we have also submitted the dossier in additional territories, positioning Adalvo as a global partner in the PAH sector.

Adalvo further highlights its position in PAH care with a comprehensive portfolio, including Riociguat and the Ambrisentan + Tadalafil fixed-dose combination, offering a range of treatment options tailored to patient needs.

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