Drugs / Recombinant human antithrombin
Recombinant human antithrombin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | ATryn | hereditary antithrombin deficiency | 2015-08-06 | “today announced that Knight’s New Drug Submission (NDS) has been accepted for review by Health Canada for ATryn® [Antithrombin (Recombinant)]” knighttx.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT00110513 | Apr 2005 → May 2008 | hereditary antithrombin deficiency | rEVO Biologics | Completed | No outcome recorded |
| Phase 3 | NCT00056550 | Dec 2002 → Feb 2004 | hereditary antithrombin deficiency | rEVO Biologics | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT02059135 Comparator | Jul 2014 → May 2016 | preeclampsia | rEVO Biologics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2016-04-25 | Knight Therapeutics (USA) Inc | Regulatory Knight Receives NOD from Health Canada for ATryn(R) knighttx.com ↗
Knight Therapeutics Inc. (TSX:GUD) (“Knight”), a leading Canadian specialty pharmaceutical company, today announced that it has received a Notice of Deficiency (“NOD”) for its ATryn ® New Drug Submission. |
| 2015-08-06 | Knight Therapeutics (USA) Inc | Regulatory Knight and LFB S.A. Announce Filing of New Drug Submission for ATryn(R) knighttx.com ↗
Knight’s New Drug Submission (NDS) has been accepted for review by Health Canada for ATryn® [Antithrombin (Recombinant)] for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2016-04-25 | Knight Therapeutics (USA) Inc | Knight Receives NOD from Health Canada for ATryn(R) knighttx.com ↗ |
| 2015-08-06 | Knight Therapeutics (USA) Inc | Knight and LFB S.A. Announce Filing of New Drug Submission for ATryn(R) knighttx.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Recombinant human antithrombin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02059135 ↗ |
| Known as | ATryn | “The purpose of the study is to assess the efficacy, safety and pharmacokinetics (PK) of recombinant human antithrombin (ATryn) in addition to expectant management for the...” NCT02059135 ↗ |
| Known as | Recombinant human antithrombin (rhAT) | “Recombinant human antithrombin (rhAT)” NCT02059135 ↗ |
| Known as | Recombinant human antithrombin (Tradename: ATryn) | “Recombinant human antithrombin (Tradename: ATryn)” NCT00110513 ↗ |
| Known as | rhAT | “Recombinant Human Antithrombin (rhAT)” NCT00056550 ↗1“Recombinant human antithrombin (rhAT)” NCT00110513 ↗ |
| Modality | Protein / enzyme biologic | “Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.” NCT00056550 ↗ |
| Route | Intravenous | “prophylactic IV administration of rhAT” NCT00056550 ↗ |