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Pfizer Announces EC Approval Of VYNDAQEL - Quick Facts

Pfizer Inc. (PFE) reported European Commission approval for VYNDAQEL, a 61 mg oral capsule, for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy. The European Commission approval of VYNDAQEL is based on results from the Phase 3 ATTR-ACT study.

"Until today, there were no approved medicines to treat patients with ATTR-CM in the EU. VYNDAQEL is now the first treatment to have two formulations approved in the EU to treat manifestations of transthyretin amyloidosis: one for cardiomyopathy, and one
for stage 1 polyneuropathy," said Paul Levesque, Global President, Pfizer Rare Disease.

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