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