NDAORALCAPSULEPriority Review
Approved
May 2019
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
4
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VYNDAQEL (tafamidis meglumine) is an oral small-molecule transthyretin (TTR) stabilizer approved by the FDA in May 2019 for the treatment of transthyretin amyloidosis (ATTR). It works by binding to and stabilizing the transthyretin protein, slowing the formation of amyloid fibrils that damage the heart and nervous system. The drug is indicated for patients with wild-type or hereditary ATTR amyloidosis.
$0.118BPart D
LOE Approaching6mo to LOEThe product is approaching loss of exclusivity in late 2026 with modest Part D spending of $118M in 2023, signaling a niche market and likely smaller commercial team focused on maximizing remaining exclusivity period.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.