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Pharmaceuticals / Submissions and Approvals

Pfizer Receives FDA Fast Track Designation for Vyndaqel

June 12, 2017
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The FDA granted a Fast Track designation to Pfizer’s Vyndaqel (tafamidis), an investigational treatment for transthyretin cardiomyopathy.

The disease is caused by the destabilization of the transthyretin protein, which can lead to heart failure. Life expectancy averages three to five years from diagnosis.

The drug is currently in a Phase III clinical trial, evaluating reductions in mortality and cardiovascular-related hospitalizations.

Vyndaqel is a transthyretin stabilizer first approved in 2011 in the European Union for the treatment of transthyretin familial amyloid polyneuropathy in adult patients.

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