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tafamidis meglumine (Vyndaqel) (Fx-1006A)

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Collapse Summary General Information
Company Pfizer Inc.
DescriptionSmall molecule that stabilizes transthyretin (TTR) protein and prevents misfolding
Molecular Target Transthyretin (TTR)
Mechanism of ActionTransthyretin (TTR) dissociation inhibitor
Therapeutic ModalitySmall molecule
Latest Stage of DevelopmentApproved
Standard IndicationAmyloidosis
Indication DetailsTreat familial amyloid polyneuropathy (FAP); Treat familial transthyretin (TTR) amyloidosis; Treat transthyretin (TTR) familial amyloid polyneuropathy (FAP); Treat transthyretin amyloid cardiomyopathy; Treat transthyretin amyloidosis in adults with symptomatic polyneuropathy; Treat transthyretin cardiomyopathy (TTR-CM)
Regulatory Designation

U.S. - Priority Review (Treat transthyretin (TTR) familial amyloid polyneuropathy (FAP));
EU - Orphan Drug (Treat familial amyloid polyneuropathy (FAP));
Japan - Orphan Drug (Treat familial amyloid polyneuropathy (FAP));
Australia - Orphan Drug (Treat transthyretin amyloidosis in adults with symptomatic polyneuropathy);
Switzerland - Orphan Drug (Treat familial amyloid polyneuropathy (FAP))

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