Drugs / Fx-1006A
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | VYNDAQEL | — | 2019-05-03 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00694161 | Aug 2008 → Jan 2010 | cardiomyopathy | Pfizer | Completed | No outcome recorded |
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT00791492 | Jul → Aug 2008 | familial amyloid neuropathy | Pfizer | Completed | No outcome recorded |
| Phase 2/3 | NCT00409175 | Jan 2007 → May 2009 | familial amyloid neuropathy | Pfizer | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT04828993 | Apr 2021 → Feb 2023 | familial amyloid neuropathy | Pfizer | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT01358565 Comparator | Nov 2010 → Apr 2011 | — | Pfizer | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2021-12-20 | Pfizer | Results Pfizer’s VYNDAQEL®/VYNDAMAX® Reduced the Risk of All-Cause Mortality by 41% Among Patients with Transthyretin Amyloid Cardiomyopathy, Five-Year Follow-Up Data Demonstrate pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today the publication of a post-hoc, interim analysis showing that treatment with VYNDAQEL ® (tafamidis meglumine) / VYNDAMAX ® (tafamidis) provided a clinically significant survival benefit at five years for patients with transthyretin amyloid cardiomyopathy (ATTR-CM). |
| 2020-11-12 | Pfizer | Results Analysis from Phase 3 ATTR-ACT and Its Long-Term Extension Study Demonstrates VYNDAQEL® 80 mg/VYNDAMAX® 61 mg Significantly Improved Survival in Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Compared to VYNDAQEL 20 mg pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today the publication of an analysis showing that VYNDAQEL ® (tafamidis meglumine) 80 mg/VYNDAMAX ® (tafamidis) 61 mg were associated with a statistically significant improvement in long-term survival in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) compared to VYNDAQEL 20 mg, reaffirming optimal dosing for these patients. |
| 2020-02-18 | Pfizer | Regulatory European Commission Approves VYNDAQEL®, the First Treatment in the EU for Transthyretin Amyloid Cardiomyopathy (ATTR-CM) pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has approved VYNDAQEL ® (tafamidis), a once-daily 61 mg oral capsule, for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). |
| 2019-12-13 | Pfizer | Regulatory Pfizer Receives Positive CHMP Opinion for VYNDAQEL® for Use in Patients with Transthyretin Amyloid Cardiomyopathy, a Rare and Fatal Disease pfizer.com ↗ |
| 2019-05-06 | Pfizer | Regulatory U.S. FDA Approves VYNDAQEL® and VYNDAMAX™ for Use in Patients with Transthyretin Amyloid Cardiomyopathy, a Rare and Fatal Disease pfizer.com ↗ |
| 2019-01-14 | Pfizer | Regulatory US FDA Accepts Regulatory Submissions for Review of Tafamidis to Treat Transthyretin Amyloid Cardiomyopathy pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the US Food and Drug Administration (FDA) accepted for filing the company’s New Drug Applications (NDAs) for tafamidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). |
| 2018-09-18 | Pfizer | Results New Sub-group Analyses from the Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) Study Presented at 2018 HFSA Annual Scientific Meeting pfizer.com ↗
A new sensitivity analysis presented today also demonstrated a significant reduction in the combination of all-cause mortality and frequency of all-cause hospitalization compared to placebo over a 30-month period (P=0.0088). |
| 2018-03-29 | Pfizer | Results Pfizer Announces Positive Topline Results From Phase 3 ATTR-ACT Study Of Tafamidis In Patients With Transthyretin Cardiomyopathy pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that the Tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study evaluating tafamidis for the treatment of transthyretin cardiomyopathy met its primary endpoint, demonstrating a statistically significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo at 30 months. |
All press releases naming this drug 9 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fx-1006A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00694161 ↗ |
| Known as | tafamidis meglumine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04828993 ↗ |
| Known as | Vyndaqel | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103837 ↗ |
| Modality | Small molecule | — CHEMBL2103837 ↗ |
| Route | Oral | “Safety and Efficacy of Orally Administered Fx-1006A” NCT00409175 ↗ |
| Target | TTR | “Therapeutic intervention with a TTR stabilizer drug, such as Fx-1006A, is hypothesized to stop progression of the disease in FAP patients.” NCT00409175 ↗ |