Pfizer's Tafamadis Gets Breakthrough Therapy Designation
Zacks Investment Research | May 23, 2018 11:08PM ET
Pfizer Inc. (NYSE:PFE) announced that the FDA has granted Breakthrough Therapy designation to its rare disease candidate, tafamidis. The candidate is being developed for the treatment of transthyretin cardiomyopathy (TTR-CM).
The designation from the FDA is intended to expedite the development and review of drugs with early evidence of substantial potential clinical benefit to patients, or benefit patients without current treatment options.
The designation for tafamadis was primarily based on encouraging top-line data from the phase III ATTR-ACT study, which demonstrated significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations in TTR-CM patients.
The candidate also enjoys fast track status and orphan drug designation for this indication in the United States.
Shares of Pfizer have declined 0.7% so far this year, comparing favorably with a 4% decrease for the Zacks Investment Research
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