Drugs / simoctocog alfa
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Nuwiq | — | 2014-07-22 | europa.eu ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT04592692 | Dec 2019 → Feb 2022 | hemophilia A | Ascension Healthcare Development Limited | Unknown | No outcome recorded |
| Phase 2 | NCT00989196 | May 2010 → Oct 2011 | hemophilia A | Octapharma | Completed | No outcome recorded |
| Phase 36 trials · 1 met primary | ||||||
| Phase 3 | NCT04030052 | Feb 2022 → Jan 2023 | hemophilia A | Emory University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02256917 | May 2015 → Sep 2018 | severe hemophilia A | Octapharma | Completed | Met primary |
| Phase 3 | NCT01992549 | Apr 2014 → Dec 2018 | severe hemophilia A | Octapharma | Completed | No outcome recorded |
| Phase 3 | NCT01863758 | Aug 2013 → Jan 2015 | severe hemophilia A | Octapharma | Completed | No outcome recorded |
| Phase 3 | NCT01712438 | Feb 2013 → Dec 2018 | severe hemophilia A | Octapharma | Completed | No outcome recorded |
| Phase 3 | NCT01341912 | Jun 2011 → Aug 2012 | severe hemophilia A | Octapharma | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05936580 | Apr 2026 → Feb 2027 expected | hemophilia A | Octapharma | Recruiting | No outcome recorded |
| Phase 4 | NCT05935358 | Nov 2023 → Aug 2026 overdue | severe hemophilia A | Octapharma | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2024-06-10 | Octapharma | Results Octapharma’s continuing dedication to improving the lives of people with rare bleeding disorders to be showcased at ISTH 2024 octapharma.com ↗
Data will be presented showing that Nuwiq ® exhibits significantly higher binding to platelets compared to comparator products, and that these differences in platelet binding may impact the efficacy of different rFVIII products in the treatment of haemophilia A. |
| 2024-05-23 | Octapharma | Results Octapharma at the forefront of rare bleeding disorders at the WFH 2024 World Congress in Madrid, Spain octapharma.com ↗ |
| 2024-01-17 | Octapharma | Results Octapharma to present clinical and scientific data at the 17th Annual Congress of the European Association for Haemophilia and Allied Disorders octapharma.com ↗
Binding of Nuwiq ® to activated platelets in vitro was found to be greater compared with other rFVIII concentrates, while in separate research Nuwiq ® showed stronger effects on endothelial cell function compared with other rFVIII concentrates: |
| 2023-10-31 | Octapharma | Results New Nuwiq® study published in the European Journal of Haematology octapharma.com ↗
Indirect comparison data indicate that personalised prophylaxis with Nuwiq ® may lead to fewer patients with haemophilia A having bleeds than with other recombinant factor VIII products. |
| 2022-12-05 | Octapharma | Results Octapharma to present new clinical data and studies at ASH 2022 to demonstrate its continued mission to meet the challenges faced by people with bleeding disorders octapharma.com ↗
Significantly higher zero bleed rates were observed in haemophilia A patients undergoing pharmacokinetic-personalised prophylaxis with Nuwiq® versus comparator products based on matching-adjusted indirect comparison (MAIC) analyses. |
| 2022-07-04 | Octapharma | Results Octapharma shares new data at ISTH2022 in its mission to meet the challenges faced by people with bleeding disorders octapharma.com ↗
These studies confirm the proven efficacy and safety profile of Nuwiq® in patients with haemophilia A. |
| 2021-02-18 | Octapharma | Results Final data from the NuProtect study published on the immunogenicity of Nuwiq® in previously untreated patients with severe haemophilia A octapharma.com ↗ |
| 2020-10-19 | Octapharma | Regulatory Octapharma announces FDA approval of updated NUWIQ® Prescribing Information to include immunogenicity data in previously untreated patients octapharma.com ↗
Octapharma is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved an updated Prescribing Information (PI) for NUWIQ®, Octapharma’s human cell line-derived recombinant factor VIII (FVIII). |
| 2020-07-13 | Octapharma | Results New data to be presented at the ISTH 2020 Virtual Congress demonstrating Octapharma’s commitment to patients with bleeding disorders octapharma.com ↗
The final results of the study showed a cumulative incidence of high-titre anti-FVIII inhibitors of 17.6%. |
| 2020-02-06 | Octapharma | Results Octapharma demonstrates commitment to improving haemophilia A treatment at the 13th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) octapharma.com ↗
The large majority (90%) of the 40 patients remained free from spontaneous bleeds during personalised prophylaxis with Nuwiq® |
| 2019-12-10 | Octapharma | Results Final results from the NuProtect study demonstrating efficacy of Nuwiq® (simoctocog alfa) in previously untreated patients (PUPs) presented at ASH 2019 octapharma.com ↗
Dr Ri Liesner from Great Ormond Street Hospital for Children, London, UK, presented for the first time the final data on the immunogenicity, efficacy and safety of Nuwiq® (simoctocog alfa) in PUPs followed for up to 100 exposure days. |
All press releases naming this drug 12 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | simoctocog alfa | “Simoctocog alfa (Nuwiq) is a B-domain deleted recombinant FVIII produced in a human cell line without chemical modification or protein fusion with proven efficacy as surgical...” PMID 41151952 ↗ Oct 20252“Intravenous co-administration of PEGLip with Simoctocog alfa” NCT04592692 ↗ “simoctocog alfa (Nuwiq®), a recombinant factor VIII (FVIII)” PMID 39624518 ↗ Dec 2024 |
| Known as | Human Cell Line-derived Recombinant Factor VIII | “Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII)” NCT01712438 ↗ |
| Known as | Human cl rhFVIII | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02256917 ↗ |
| Known as | Nuwiq | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04030052 ↗ |
| Known as | Vihuma | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108319 ↗ |
| Action | Restore | “a prophylactic FVIII replacement therapy” NCT04592692 ↗ |
| Modality | Protein / enzyme biologic | “human cell-line derived recombinant FVIII concentrate” NCT00989196 ↗ |
| Route | Intravenous | “administered intravenously” NCT01341912 ↗ |
| Target | F8 | “Coagulation factor VIII exogenous protein” CHEMBL2108319 ↗ |