NDAORALCAPSULEPriority Review
Approved
May 2019
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
4
Data completeness
6/8 — Strong
Priority Review
VYNDAQEL (tafamidis meglumine) by Pfizer. Approved for transthyretin amyloid polyneuropathy. First approved in 2019.
VYNDAQEL (tafamidis meglumine) is an oral capsule medication developed by Pfizer and approved by the FDA on May 3, 2019. The mechanism of action and specific indications are not detailed in the available data. The product represents a small-molecule therapeutic approach to a defined patient population, with oral administration enabling convenient outpatient management.
$0.1BPart D
8mo to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (1)
Clinical Trials (4)
To Evaluate the Efficacy and Safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients With Transthyretin Amyloid Polyneuropathy
Started Jun 2025
15 enrolled
Transthyretin Amyloid Polyneuropathy
The Effect Of Tafamidis Meglumine In Transthyretin Amyloid Polyneuropathy Patients
Started Apr 2021
15 enrolled
Transthyretin Amyloid Polyneuropathy (ATTR-PN)
Vyndaqel Capsules Special Investigation (ATTR-CM)
Started Oct 2019
1,214 enrolled
Transthyretin (TTR) Amyloid Cardiomyopathy
Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Started Jan 2014
500 enrolled
Transthyretin Familial Amyloid Polyneuropathy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.