Drugs / omefas
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | Epanova | hypertriglyceridemia 2 | — | “The NDA submission for Epanova was filed by Omthera Pharmaceuticals, now a wholly-owned subsidiary of AstraZeneca, as a 505(b)(1) application in July 2013.” astrazeneca.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01486433 | Nov 2011 → Mar 2012 | hypertriglyceridemia | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01431690 | Aug → Oct 2011 | hypertriglyceridemia | AstraZeneca | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT01242527 | Jan 2011 → Mar 2012 | — | AstraZeneca | Completed | Met primary |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-01-13 | AstraZeneca | Update on Phase III STRENGTH trial for Epanova in mixed dyslipidaemia astrazeneca.com ↗ |
| 2014-05-06 | AstraZeneca | US FDA approves EPANOVA for the treatment of adults with severe hypertriglyceridaemia astrazeneca.com ↗ |
| 2013-09-18 | AstraZeneca | FDA accepts new drug application for investigational compound Epanova for the treatment of severe hypertriglyceridaemia astrazeneca.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | omefas | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01431690 ↗ |
| Known as | Epanova | “Efficacy and Safety of Epanova® (Omefas) in Severe Hypertriglyceridemia” NCT01242527 ↗ |