Pfizer Gets FDA Approval for Transthyretin-Mediated Amyloidosis Treatments
May 06 2019 - 07:38AM
Dow Jones News
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.
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