Drugs / Recombinant single-chain factor VIII
Recombinant single-chain factor VIII
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | hemophilia B leyden | 2015-12-22 | “The MAA is based on the AFFINITY clinical development program, which includes a phase I/III open-label, multi-center trial examining safety and efficacy.” csl.com ↗ |
| Filed | US (FDA) | — | hemophilia B leyden | 2015-07-28 | “The BLA submission is based on the AFFINITY clinical development program, which includes a phase I/III open-label, multi-center trial examining safety and efficacy.” csl.com ↗ |
| Filed | Japan (PMDA) | — | hemophilia B leyden | — | “NDA in Japan was submitted based on the completed two pivotal studies for review” csl.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT06738485 | Jan 2025 → Oct 2026 expected | hemophilia A | CSL Behring | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| 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 ↗ |
| 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 ↗
10 Jul 2017 BERLIN — 10 July 2017 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). |
| 2017-01-09 | CSL Behring | Regulatory AFSTYLA®, for Haemophilia A, Receives European Commission Approval csl.com ↗
Global biotherapeutics leader CSL Behring announced today that the European Commission has granted marketing authorisation for AFSTYLA ® [Recombinant Human Coagulation Factor VIII, Single Chain] for children and adults with haemophilia A. |
| 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. |
| 2016-11-14 | CSL Behring | Regulatory AFSTYLA®, for Haemophilia A, Receives Positive Opinion from European Medicines Agency CHMP csl.com ↗
Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AFSTYLA® [Recombinant Human Coagulation Factor VIII, Single Chain] for patients with haemophilia A. |
| 2016-07-27 | CSL Behring | Results CSL Behring Presents Pivotal Efficacy Data for AFSTYLA® In Adolescents and Children with Hemophilia A at the World Federation of Hemophilia 2016 World Congress csl.com ↗
Overall, the efficacy of AFSTYLA to treat bleeding events in patients on prophylaxis or on-demand regimens was rated as excellent or good by investigators in 96.3 percent of all bleeding events (total of 347 treated events). |
| 2016-05-26 | CSL Behring | Regulatory 20 U.S. FDA Approves CSL Behring’s AFSTYLA®-- The First and Only Recombinant Factor VIII Single Chain Therapy for Hemophilia A csl.com ↗
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved AFSTYLA ® [Antihemophilic Factor (Recombinant), Single Chain], 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 ↗
Global biotherapeutics leader 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 ↗
Patients using rVIII-SingleChain to prevent bleeding had low annualized bleeding rates (median ABR of 1.14), and an annualized spontaneous bleeding rate (AsBR) of 0.00. |
| 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 14 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Recombinant single-chain factor VIII | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06738485 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant single-chain factor VIII (rVIII-SingleChain)” NCT06738485 ↗ |
| Route | Intravenous | “Participants will receive rVIII-SingleChain as an intravenous (IV) infusion” NCT06738485 ↗ |