By Chris Wack

 

Pfizer Inc. (PFE) said Monday that the U.S. Food and Drug Administration has approved both Vyndaqel, or tafamidis meglumine, and Vyndamax (tafamidis) for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.

The health-care company said in a release that Vyndaqel and Vyndamax are two oral formulations of the first-in-class transthyretin stabilizer tafamidis, and the first and only medicines approved by the FDA to treat hereditary transthyretin-mediated amyloidosis.

Pfizer said that about 100,000 people in the U.S. have hereditary transthyretin-mediated amyloidosis.

The company said that approved recommended dosage is either Vyndaqel 80 mg orally once-daily, taken as four 20 mg capsules, or Vyndamax 61 mg orally once-daily, taken as a single capsule.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

May 06, 2019 07:23 ET (11:23 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
Pfizer (NYSE:PFE)
Historical Stock Chart
From Feb 2024 to Mar 2024 Click Here for more Pfizer Charts.
Pfizer (NYSE:PFE)
Historical Stock Chart
From Mar 2023 to Mar 2024 Click Here for more Pfizer Charts.