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Adalvo Submits Dual DCPs for Tafamidis, Advancing Launch Readiness in Europe

Business
31 July 2025

Adalvo confirms the submission of DCP applications for both Tafamidis Meglumine 20mg and Tafamidis 61mg soft gel capsules, marking a key milestone in its strategy to expand access to treatment options for Transthyretin Amyloid Cardiomyopathy (ATTR-CM). 

These submissions demonstrate tangible progress in Adalvo’s plan to deliver a Day 1 launch across key European markets, building on its strong regulatory planning and rare disease expertise. Tafamidis remains the only approved oral therapy for ATTR-CM, a serious and progressive condition that significantly impacts cardiovascular health and survival. 

Adalvo’s Tafamidis development program is supported by a robust IP strategy and specialised technical capabilities, reflecting the complexity of this high-barrier product. The successful submission of both formulations highlights Adalvo’s ability to execute at pace on rare disease assets with high clinical and commercial relevance. 

With global sales reaching $6.2 billion in 2024 (IQVIA) and a 3-year CAGR of 34%, Tafamidis continues to stand out as one of the most valuable rare disease therapies worldwide. 

Adalvo remains focused on being a first mover in key regions, delivering differentiated, partner-ready assets that combine therapeutic relevance with long-term commercial potential. 

To explore licensing or commercial opportunities for Tafamidis or within Adalvo’s rare disease portfolio, contact the team today