Drugs / Albutrepenonacog Alfa
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Idelvion | — | 2016-05-11 | europa.eu ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT04108260 | Apr 2020 → Nov 2021 | hemophilia | National Taiwan University Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2016-10-03 | CSL Behring | Regulatory Therapeutic Goods Administration Approves IDELVION® - CSL Behring’s Novel Recombinant Haemophilia B Treatment with up to 14-day Dosing Intervals csl.com ↗
CSL Behring announced that the Australian Therapeutic Goods Administration (TGA) has approved IDELVION ® [albutrepenonacog alfa] in patients with haemophilia B (congenital factor IX deficiency). |
| 2016-09-29 | CSL Behring | Regulatory Japan’s Ministry of Health, Labour and Welfare (MHLW) Approves CSL Behring’s IDELVION® -- The First and Only Hemophilia B Therapy with Up to 14-day Dosing Intervals csl.com ↗
Global biotherapeutics leader CSL Behring announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved IDELVION ® [Albutrepenonacog Alfa], its innovative, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the prevention of bleeding tendency in patients with factor IX deficiency. |
| 2016-05-11 | CSL Behring | Regulatory European Commission Approves IDELVION® -- CSL Behring’s Novel Hemophilia B Treatment with Up to 14-day Dosing Intervals csl.com ↗
CSL Behring announced today that the European Commission has approved IDELVION® [albutrepenonacog alfa], its innovative, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency). |
All press releases naming this drug 3 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Albutrepenonacog Alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04108260 ↗ |
| Known as | CSL-654 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5315076 ↗ |
| Known as | IDELVION | “Albutrepenonacog Alfa 1 UNT [IDELVION]” NCT04108260 ↗ |
| Modality | Protein / enzyme biologic | “The Effectiveness of Recombinant Fusion Protein Linking Coagulation Factor IX With Recombinant Albumin (rIX-FP) in Severe Hemophilia B Patients Switching From Previous Factor...” NCT04108260 ↗ |
| Target | F9 | “Coagulation factor IX exogenous protein” CHEMBL5315076 ↗ |