Pfizer: FDA accepts filing for rare disease drug
(CercleFinance.com) - Pfizer said on Monday that the US Food and Drug Administration has accepted for review the filing of a new drug application for the treatment of transthyretin amyloid cardiomyopathy, a rare but fatal condition.
The "tafamidis meglumine" form of the drug has been granted priority review, with the FDA set to take a decision in July 2019, Pfizer said, while the tafamidis free acid form will be under standard review, with an expected action date in November 2019.
Under one percent of patients living with transthyretin amyloid cardiomyopathy are currently diagnosed, as symptoms are very similar to more common causes of heart failure.
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