Drugs / LONOCTOCOG ALFA
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | hemophilia B leyden | 2015-12-22 | “the company has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its novel investigational recombinant factor VIII...” csl.com ↗ |
| Filed | US (FDA) | — | hemophilia B leyden | 2015-07-28 | “Food and Drug Administration has accepted for review the company’s Biologics License Application (BLA) for its novel investigational recombinant factor VIII single-chain...” csl.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT01486927 | Feb 2012 → Dec 2014 | hemophilia A | CSL Behring | Completed | Met primary |
| Phase 32 trials | ||||||
| Phase 3 | NCT02172950 | Oct 2014 → Jan 2021 | severe hemophilia A | CSL Behring | Completed | No outcome recorded |
| Phase 3 | NCT02093897 | Mar 2014 → Aug 2015 | hemophilia A | CSL Behring | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2017-09-28 | CSL Behring | Regulatory Japan’s Ministry of Health, Labour and Welfare Approves AFSTYLA® - CSL Behring’s Novel Recombinant Haemophilia A Treatment csl.com ↗
Global biotherapeutics leader CSL Behring today announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved AFSTYLA ® (hereafter AFSTYLA ) [lonoctocog alfa] a recombinant single-chain coagulation factor VIII (rVIII-SingleChain) in patients with haemophilia A (congenital factor VIII deficiency). |
| 2017-07-10 | CSL Behring | Results New Findings Show AFSTYLA® Provides Long-lasting Efficacy without Increased Product Consumption for Prophylactic and On-Demand Treatment of Haemophilia A csl.com ↗
CSL Behring today presented data finding treatment with AFSTYLA® may result in low average product consumption without compromising efficacy in both the prophylaxis and on-demand settings. |
| 2017-04-19 | CSL Behring | Regulatory Therapeutic Goods Administration Approves AFSTYLA® - CSL Behring’s Novel Recombinant Haemophilia A Treatment csl.com ↗
Global biotherapeutics leader, CSL Behring today announced that the Australian Therapeutic Goods Administration (TGA) has approved AFSTYLA ® [lonoctocog alfa] a recombinant single chain coagulation factor VIII (rFVIIISingleChain) in patients with haemophilia A (congenital factor VIII deficiency). |
| 2016-12-14 | CSL Behring | Regulatory Health Canada Approves CSL Behring’s AFSTYLA™ for the Treatment of Hemophilia A csl.com ↗
Global biotherapeutics leader CSL Behring announced that Health Canada has approved AFSTYLA [Antihemophilic Factor VIII (Recombinant), SingleChain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A. |
| 2015-12-22 | CSL Behring | Regulatory CSL Behring Submits Marketing Authorization Application to the European Medicines Agency for rVIII-SingleChain for Patients with Hemophilia A csl.com ↗
CSL Behring announced today that the company has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its novel investigational recombinant factor VIII single-chain (rVIII-SingleChain) for the treatment of hemophilia A. |
| 2015-07-28 | CSL Behring | Regulatory U.S. FDA Accepts for Review CSL Behring’s Biologics License Application for Its Novel rVIII-SingleChain Therapy for Patients with Hemophilia A csl.com ↗ |
| 2015-06-24 | CSL Behring | Results CSL Behring Announces Pivotal Data of Novel rVIII-SingleChain Therapy in Adolescents and Adults with Hemophilia A csl.com ↗
Overall, patients using rVIII-SingleChain to prevent bleeding (prophylaxis) were well controlled with two to three infusions per week and developed no inhibitors. |
| 2013-07-03 | CSL Behring | Results CSL Behring Announces Results from Study of Recombinant Single-Chain Factor VIII (rVIII-SingleChain) for Treatment of Hemophilia A csl.com ↗
CSL Behring today announced that pharmacokinetic results for its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) showed improved half-life over octocog alfa (the comparator). |
All press releases naming this drug 19 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LONOCTOCOG ALFA | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594603 ↗ |
| Known as | Afstyla | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594603 ↗ |
| Known as | CSL627 | “rVIII-SingleChain, CSL627” NCT02172950 ↗ |
| Known as | Recombinant VIII (rVIII)-SingleChain | “Recombinant VIII (rVIII)-SingleChain is a novel B-domain-truncated recombinant factor VIII (rFVIII), comprised of covalently bonded factor VIII (FVIII) heavy and light chains.” PMID 27330001 ↗ Jun 2016 |
| Known as | rVIII-SingleChain | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02172950 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant VIII (rVIII)-SingleChain is a novel B-domain-truncated recombinant factor VIII (rFVIII), comprised of covalently bonded factor VIII (FVIII) heavy and light chains.” PMID 27330001 ↗ Jun 2016 |
| Route | Intravenous | “single intravenous infusion” NCT01486927 ↗ |
| Target | F8 | “Coagulation factor VIII exogenous protein” CHEMBL4594603 ↗ |