Adalvo continues to make good progress towards the approval and Day-1 launch of Tafamidis 61mg soft gel capsules.
Following CP and DCP submission for Tafamidis base 61mg in Europe, this milestone reinforces the exceptional quality and commercial readiness of Adalvo’s dossier for this high-barrier orphan drug.
Based on the reference brand, Vyndamax®, Tafamidis 61mg is the only approved single-capsule, once-daily oral treatment specifically indicated for Hereditary Transthyretin-Related Amyloidosis Cardiomyopathy (ATTR-CM)—a serious, progressive condition impacting cardiovascular health and patient survival.
Tafamidis continues to stand out as one of the world’s most valuable rare disease therapies. According to IQVIA, Tafamidis 61mg demonstrated exceptional growth between mid-2023 and mid-2025 with a CAGR of 63%, reaching a MAT of $7.04bn in June 2025.
With a clearly defined IP pathway and highly competitive CoGs, Adalvo is one of the few pharmaceutical companies positioned to offer partners a scarce, winning product for a Day-1 launch. This ensures both affordability for healthcare systems and robust commercial returns for our partners.
To explore licensing or commercial opportunities for Tafamidis or within Adalvo’s wider rare disease and cardiology portfolios, contact our team today.
Note: For the treatment of wild-type transthyretin amyloidosis with cardiomyopathy (ATTR-CM) in adult patients, another authorized medicinal product containing Tafamidis indicated for this condition should be used.