Drugs / nonacog beta pegol
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hemophilia B leyden 2 milestones | |||||
| Filed | US (FDA) | — | hemophilia B leyden | 2016-05-16 | “indsendt registreringsansøgning (Biologics License Application) til de amerikanske sundhedsmyndigheder (FDA) for langtidsvirkende faktor IX, nonacog beta pegol.” novonordisk.com ↗ “submission to the US Food and Drug Administration (FDA) of the Biologics License Application for the approval of long-acting factor IX, nonacog beta pegol.” novonordisk.com ↗ |
| Filed | EU (EMA) | — | hemophilia B leyden | 2016-01-07 | “submission to the European Medicines Agency of the Marketing Authorisation Application for the approval of long-acting factor IX, nonacog beta pegol.” novonordisk.com ↗ “indsendt ansøgning om markedsføringstilladelse til Det Europæiske Lægemiddelagentur for langtidsvirkende faktor IX, nonacog beta pegol.” novonordisk.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Refixia | — | 2017-06-02 | europa.eu ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT03075670 | Mar → Dec 2017 | congenital hematological disorder, hemophilia B | Novo Nordisk A/S | Completed | Met primary |
| Phase 1 | NCT00956345 | Aug 2009 → Jul 2010 | hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT05365217 | May 2022 → Apr 2024 | hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT02141074 | Jul 2014 → Oct 2022 | congenital hematological disorder, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01386528 | Jun 2012 → Dec 2013 | congenital hematological disorder, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01467427 | May 2012 → Nov 2023 | hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01395810 | Apr 2012 → Mar 2014 | congenital hematological disorder, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01333111 | Apr 2011 → Mar 2013 | congenital hematological disorder, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2017-06-06 | Novo Nordisk A/S | Regulatory Refixia® (nonacog beta pegol; N9-GP) godkendt i EU novonordisk.com ↗
Novo Nordisk meddeler i dag, at Europa-Kommissionen har givet markedsføringstilladelse til Refixia® til behandling af unge og voksne med hæmofili B. |
| 2017-06-06 | Novo Nordisk A/S | Regulatory Refixia® (nonacog beta pegol; N9-GP) approved in the EU novonordisk.com ↗
Novo Nordisk today announced that the European Commission has granted marketing authorisation for Refixia® for the treatment of adolescents and adults with haemophilia B. |
| 2017-05-31 | Novo Nordisk A/S | Regulatory Novo Nordisk får FDA-godkendelse for REBINYN® (nonacog beta pegol; N9-GP) i USA novonordisk.com ↗
Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder, FDA, har godkendt registreringsansøgningen (Biologics License Application) for REBINYN® til behandling af voksne og børn med hæmofili B. |
| 2017-05-31 | Novo Nordisk A/S | Regulatory Novo Nordisk receives US FDA approval of REBINYN® (nonacog beta pegol; N9-GP) novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN® for the treatment of adults and children with haemophilia B. |
| 2017-03-24 | Novo Nordisk A/S | Regulatory Novo Nordisk receives positive opinion from the European regulatory authorities for Refixia® (nonacog beta pegol, N9-GP) for the treatment of haemophilia B novonordisk.com ↗ |
| 2017-03-24 | Novo Nordisk A/S | Regulatory Novo Nordisk får positiv udtalelse fra de europæiske lægemiddelmyndigheder om Refixia® (nonacog beta pegol, N9-GP) til behandling af hæmofili B novonordisk.com ↗
Bagsværd, den 24. marts 2017 - Novo Nordisk meddeler i dag, at Udvalget for Humanmedicinske Lægemidler (CHMP) under Det Europæiske Lægemiddelagentur (EMA) har afgivet en positiv udtalelse om brug af Refixia® (nonacog beta pegol, N9-GP) og anbefaler markedsføringstilladelse til behandling af unge og voksne med hæmofili B. |
| 2016-05-16 | Novo Nordisk A/S | Regulatory Novo Nordisk indsender registreringsansøgning i USA for langtidsvirkende faktor IX til behandling af hæmofili B novonordisk.com ↗
Novo Nordisk meddeler i dag, at virksomheden har indsendt registreringsansøgning (Biologics License Application) til de amerikanske sundhedsmyndigheder (FDA) for langtidsvirkende faktor IX, nonacog beta pegol. |
| 2016-05-16 | Novo Nordisk A/S | Regulatory Novo Nordisk files for regulatory approval in the US of long-acting factor IX for the treatment of haemophilia B novonordisk.com ↗
Novo Nordisk today announced the submission to the US Food and Drug Administration (FDA) of the Biologics License Application for the approval of long-acting factor IX, nonacog beta pegol. |
| 2016-01-07 | Novo Nordisk A/S | Regulatory Novo Nordisk indsender registreringsansøgning i EU for langtidsvirkende faktor IX til behandling af hæmofili B novonordisk.com ↗
Novo Nordisk meddeler i dag, at virksomheden har indsendt ansøgning om markedsføringstilladelse til Det Europæiske Lægemiddelagentur for langtidsvirkende faktor IX, nonacog beta pegol. |
| 2016-01-07 | Novo Nordisk A/S | Regulatory Novo Nordisk files for regulatory approval of long-acting factor IX in the EU for the treatment of haemophilia B novonordisk.com ↗
Novo Nordisk today announced the submission to the European Medicines Agency of the Marketing Authorisation Application for the approval of long-acting factor IX, nonacog beta pegol. |
| 2013-05-17 | Novo Nordisk A/S | Results Novo Nordisk rapporterer positive resultater fra det første fase 3-studie med langtidsvirkende faktor IX til behandling af hæmofili B novonordisk.com ↗ |
| 2013-05-17 | Novo Nordisk A/S | Results Novo Nordisk reports positive results from first phase 3 trial with long-acting factor IX for treatment of haemophilia B novonordisk.com ↗ |
All press releases naming this drug 14 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nonacog beta pegol | “Nonacog beta pegol (N9-GP) and recombinant factor IX-Fc fusion protein (rFIXFc) are extended half-life rFIX compounds.” PMID 31011711 ↗ Mar 2019 |
| Known as | N9-GP | “This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.” NCT02141074 ↗4“The study investigates how well the medicine called nonacog beta pegol (N9-GP) works in Chinese people with haemophilia B.” NCT05365217 ↗ “prophylactic nonacog beta pegol (N9-GP) in previously treated patients (PTPs) aged ≤ 12 years with HB (FIX activity ≤ 2%).” PMID 32369845 ↗ May 2020 “Nonacog beta pegol (N9-GP) and recombinant factor IX-Fc fusion protein (rFIXFc) are extended half-life rFIX compounds.” PMID 31011711 ↗ Mar 2019 “Nonacog beta pegol (N9-GP) in haemophilia B: A multinational phase III safety” PMID 26970716 ↗ Mar 2016 |
| Known as | NNC-0156-0000-0009 | “This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at...” NCT01333111 ↗ |
| Known as | Rebinyn | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108348 ↗ |
| Known as | Refixia | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108348 ↗ |
| Modality | Protein / enzyme biologic | “Pegylated Recombinant Factor IX (nonacog beta pegol)” NCT00956345 ↗ |
| Route | Intravenous | “administered intravenously (into the vein)” NCT00956345 ↗ |
| Target | F9 | “Coagulation factor IX exogenous protein” CHEMBL2108348 ↗ |