Parallel regulatory routes position a high-value rare disease asset for Day-1 launches across Europe.
Zug, Switzerland, 24th July 2026 — Adalvo today announced two regulatory milestones for its generic Tafamidis 61mg soft gel capsules. Adalvo has secured DCP approval and has received a positive CHMP opinion under the Centralised Procedure, providing coverage across all EU markets. Together, the two routes deliver comprehensive European reach, positioning Adalvo and its commercial partners for Day-1 launches upon expiry of applicable exclusivities and IP rights.
Developed based on the reference brand Vyndaqel® 61mg soft capsules, Tafamidis is indicated for the treatment of hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM), a serious and progressive condition in which abnormal protein deposits accumulate in the heart, impairing its function over time.
Improvements in clinical awareness mean that patient numbers are rising steadily. As the only approved single-capsule, once-daily oral treatment for ATTR-CM, Tafamidis is one of the world’s most commercially significant rare disease therapies.
Global sales of the Tafamidis franchise reached $6.38 billion in 2025, up 17% year on year. Growth was strongest outside the United States, where international revenues rose 34% to $2.55 billion, reflecting accelerating diagnosis rates and sustained demand across European and other developed markets.
These milestones reflect Adalvo’s long-term investment in complex rare disease development and its clearly defined intellectual property strategy, which together support a first-wave launch opportunity across priority European markets. Both the DCP and Centralised submission processes have been navigated with precision, reflecting the exceptional quality of Adalvo’s Tafamidis dossier, and positioning Adalvo as one of the few pharmaceutical companies with both the technical capability and the commercial readiness to deliver a partner-ready asset at launch.
Adalvo’s CEO, Anil Okay, commented: “Tafamidis is a clear example of Adalvo’s growing strength in complex rare disease therapies. Securing approval on an asset of this commercial and clinical standing takes deep technical capability and precise regulatory execution. Achieving it through two parallel European routes speaks to the strength of both our dossier and our partnerships. I’m proud of the team, and proud that Adalvo continues to give partners access to differentiated therapies in the areas where patients need them most.”
These milestones reflect Adalvo’s commitment to advancing high-quality, differentiated generic medicines and expanding future treatment options for patients through rigorous development and regulatory execution.
Vyndaqel® is a registered trademark of Pfizer Inc.