PFE Pfizer Inc

   By Colin Kellaher 
 

Pfizer Inc. (PFE) on Monday said the U.S. Food and Drug Administration accepted its new-drug applications for tafamidis for the rare and progressive disease transthyretin amyloid cardiomyopathy, or ATTR-CM.

The New York drug maker said it submitted a pair of NDAs based on two forms of tafamidis, meglumine salt and free acid, adding that the FDA granted priority review to the meglumine form.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months.

Pfizer said the FDA set a target action date in July for the meglumine form and November for the free acid form, which is under standard review.

Pfizer said ATTR-CM is a rare, fatal and often underdiagnosed condition that can lead to heart failure. In a phase 3 study, tafamidis showed a significant reduction in the hierarchical combination of all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo in patients with ATTR-CM.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

January 14, 2019 08:52 ET (13:52 GMT)

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