Adalvo is preparing to submit DCP applications for both Tafamidis Meglumine 20mg and Tafamidis Base 61mg soft gel capsules in July 2025, strengthening its strategic commitment to expanding access to treatments for Transthyretin-Related Amyloidosis (ATTR-CM).
Tafamidis remains the only approved oral treatment for ATTR cardiomyopathy, a progressive and life-threatening rare disease. The product plays a central role in reducing cardiovascular mortality and improving patient outcomes.
According to IQVIA, Tafamidis achieved global sales of $6.2 billion in 2024, with a 3Y CAGR of 34%, positioning it as one of the most commercially significant rare disease therapies worldwide.
Adalvo’s programs are supported by a strong IP strategy, state-of-the-art manufacturing capabilities, and a clearly defined regulatory pathway, with both formulations targeted for Day 1 launch readiness.
Tafamidis is a technically challenging product to develop and produce, and Adalvo’s approach is built around ensuring clinical relevance, quality, and supply security.
Adalvo aims to be a first mover in key target markets, expanding its rare disease portfolio with differentiated, partner-ready assets that address high unmet medical needs
To explore licensing or commercial opportunities within Adalvo’s rare disease portfolio, contact the team today.