Drugs / rIX-FP
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | hemophilia B leyden | 2015-12-21 | “submitted its new drug application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its investigational fusion protein linking recombinant coagulation factor IX...” csl.com ↗ |
| Filed | Other | — | hemophilia B leyden | 2015-07-28 | “Swissmedic has accepted for review a Marketing Authorization Application (MAA) for the company’s investigational long-acting fusion protein linking recombinant coagulation...” csl.com ↗ |
| Filed | EU (EMA) | — | hemophilia B leyden | 2015-03-30 | “EMA beginning its Centralized Procedure for rIX-FP is a significant milestone for CSL Behring’s recombinant factor IX clinical development program” csl.com ↗ “the European Medicines Agency (EMA) started the Centralized Procedure for reviewing its MAA for rIX-FP” csl.com ↗ |
| Filed | US (FDA) | — | hemophilia B leyden | 2014-12-16 | “submission of our BLA to the FDA for rIX-FP is a significant milestone for CSL Behring’s recombinant factor IX development program” csl.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT01496274 | Feb 2012 → Jul 2014 | hemophilia B | CSL Behring | Completed | Met primary |
| Phase 33 trials | ||||||
| Phase 3 | NCT06399289 | Jul 2024 → Dec 2026 expected | hemophilia B | CSL Behring | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02053792 | Feb 2014 → Jun 2021 | hemophilia B | CSL Behring | Completed | No outcome recorded |
| Phase 3 | NCT01662531 | Jan 2013 → Oct 2014 | hemophilia B | CSL Behring | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2017-07-12 | CSL Behring | Results New Data Demonstrate Prophylactic Treatment with IDELVION® Reduces Bleed Frequency and Has Potential to Positively Impact Patients with Hemophilia B csl.com ↗
12 Jul 2017 BERLIN — 12 July 2017 CSL Behring today presented data finding that prophylaxis treatment with IDELVION ® provides consistently high factor IX levels, resulting in low bleeding rates in both adult and paediatric patients with haemophilia B. |
| 2016-07-26 | CSL Behring | Results CSL Behring Presents Phase III Data for IDELVION® for Hemophilia B at the World Federation of Hemophilia 2016 World Congress csl.com ↗
The results showed that extended prophylaxis treatment regimens effectively prevented bleeds while also reducing overall IDELVION consumption. |
| 2016-04-05 | CSL Behring | Regulatory European Medicines Agency Supports Maintaining Orphan Designation for IDELVION® csl.com ↗
05 Apr 2016 CSL Behring announced today that the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) supports maintaining the orphan designation for IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein]. |
| 2015-12-21 | CSL Behring | Regulatory CSL Behring Submits New Drug Application to Japan’s Pharmaceuticals and Medical Devices Agency for rIX-FP for Hemophilia B Patients csl.com ↗
CSL Behring announced today that the company has submitted its new drug application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its investigational fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). |
| 2015-12-07 | CSL Behring | Results CSL Behring Presents Phase III Data for Its Long-Acting Recombinant Factor IX Albumin Fusion Protein for Hemophilia B at the 57th ASH Annual Meeting & Exposition csl.com ↗
Global biotherapeutics leader CSL Behring today presented data from its Phase III PROLONG-9FP clinical program evaluating the efficacy and long-term safety of its investigational long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). |
| 2015-07-28 | CSL Behring | Regulatory Swissmedic Accepts for Review CSL Behring’s MAA for rIX-FP for Patients with Hemophilia B csl.com ↗ |
| 2015-06-24 | CSL Behring | Results CSL Behring Presents rIX-FP for Hemophilia B Phase III Data Evaluating Efficacy, Safety and Improved Dosing at ISTH 2015 csl.com ↗
CSL Behring today presented data from Phase III studies evaluating the efficacy and long-term safety of its investigational long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). |
| 2015-03-30 | CSL Behring | Regulatory European Medicines Agency Commences Review of CSL Behring's Regulatory Submission for rIX-FP for Hemophilia B Patients csl.com ↗ |
| 2015-02-04 | CSL Behring | Regulatory CSL Behring Achieves Another Key Milestone in PROLONG-9FP, its Recombinant Factor IX Fusion Protein Development Program; Continues to Advance CSL Behring’s Legacy of Improving Patient Well-Being csl.com ↗
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). |
| 2014-12-16 | CSL Behring | Regulatory CSL Behring Submits Biologics License Application for FDA Approval of Recombinant Fusion Protein Linking Coagulation Factor IX with Recombinant Albumin (rIX-FP) for Hemophilia B Patients csl.com ↗
submission of our BLA to the FDA for rIX-FP is a significant milestone for CSL Behring’s recombinant factor IX development program and moves us one step closer to bringing this innovative therapy to hemophilia B patients in the U.S. |
| 2014-05-12 | CSL Behring | Results New Findings Support Less Frequent Dosing in Hemophilia B Patients Treated with Coagulation Factor IX with Recombinant Albumin (rIX-FP) csl.com ↗
These findings suggest an improvement in hemophilia B treatment by allowing a prolonged routine prophylaxis treatment interval of 14 days or potentially longer, compared to the current standard of two to three times per week. |
| 2013-07-03 | CSL Behring | Results International Trial Shows Clinical Efficacy of Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) for Once Weekly Prophylaxis in Patients with Severe Hemophilia B csl.com ↗
Data presented by CSL Behring today showed clinical efficacy of a once-weekly dosing regimen of recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP). |
| 2013-07-03 | CSL Behring | Results CSL Behring Presents Population Pharmacokinetic Model for Novel Recombinant Factor IX Hemophilia B Treatment That Supports Less Frequent Administration csl.com ↗
03 Jul 2013 CSL Behring today presented a population pharmacokinetic model for recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam. |
| 2012-06-08 | CSL Behring | Regulatory CSL Behring Receives FDA Orphan Drug Designation for rIX-FP, a Novel Therapy in Development to Treat Congenital Factor IX Deficiency (Hemophilia B) csl.com ↗
08 Jun 2012 CSL Behring announced today that the company has been granted orphan drug designation by the United States Food and Drug Administration for its novel recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP). |
| 2012-02-02 | CSL Behring | Results International Phase I Trial Results of Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) Show All Pharmacokinetic Parameters Significantly Improved in Patients with Severe Hemophilia B csl.com ↗
02 Feb 2012 CSL Behring today announced the results of a Phase I study evaluating recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP) in patients with severe hemophilia B. |
All press releases naming this drug 19 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rIX-FP | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02053792 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant IX-FP (rIX-FP) is a fusion protein” NCT01496274 ↗ |
| Route | Intravenous | “administered by intravenous administration” NCT01496274 ↗ |