Nonacog beta pegol

Overview

Nonacog beta pegol is a recombinant coagulation factor IX derivative. It is produced without animal-derived materials and with an attached 40kDa polyethylene glycol (PEG) molecule for peptide activation by a site-directed glycoPEGylation. Once activated, the activation molecule with PEG is cleaved to leave the activated factor IX (Factor IXa). Nonacog beta pegol was developed by Novo Nordisk and received its first global approval by the FDA on May 31, 2017, followed by the European Commission approval on June 2, 2017. Nonacog beta pegol was approved by Health Canada on November 29, 2017.

Indication

Nonacog beta pegol is indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for control and prevention of bleeding episodes as well as control and prevention of bleeding in the perioperative setting. It is also used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Associated Conditions

Bleeding caused by Hemophilia B

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia B	2022/05/09	NCT05365217	Phase 3	Completed	Novo Nordisk A/S
Post-marketing Surveillance (Use Result Surveillance) With Refixia®	2019/03/14	NCT03875547	N/A	ENROLLING_BY_INVITATION	Novo Nordisk A/S
A Study Following Males With Haemophilia B on Prophylaxis With Refixia/REBINYN	2018/11/19	NCT03745924	N/A	ENROLLING_BY_INVITATION	Novo Nordisk A/S
Adverse Event Data Collection From External Registries on Nonacog Beta Pegol	2018/10/01	NCT03690336	N/A	ENROLLING_BY_INVITATION	Novo Nordisk A/S
A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B	2017/03/09	NCT03075670	Phase 1	Completed	Novo Nordisk A/S
Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B	2014/05/19	NCT02141074	Phase 3	Completed	Novo Nordisk A/S
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.	2011/11/08	NCT01467427	Phase 3	Completed	Novo Nordisk A/S
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773	2011/07/18	NCT01395810	Phase 3	Completed	Novo Nordisk A/S
Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B	2011/07/01	NCT01386528	Phase 3	Completed	Novo Nordisk A/S
Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients	2011/04/11	NCT01333111	Phase 3	Completed	Novo Nordisk A/S

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Refixia	Novo Nordisk A/S,Novo Alle,2880 Bagsvaerd,Denmark	Authorised	6/2/2017

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
REFIXIA nonacog beta pegol 1000 IU powder and solvent for solution for injection	308425	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	9/4/2019
REFIXIA nonacog beta pegol 2000 IU powder and solvent for solution for injection	308424	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	9/4/2019
REFIXIA nonacog beta pegol 500 IU powder and solvent for solution for injection	308426	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	9/4/2019
REFIXIA nonacog beta pegol 3000 IU powder and solvent for solution for injection	427218	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	11/12/2024

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
REFIXIA 1000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Novo Nordisk A/S	1171193002	POLVO Y SOLUCIÓN PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
REFIXIA 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Novo Nordisk A/S	1171193001	POLVO Y SOLUCIÓN PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
REFIXIA 3000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Novo Nordisk A/S	1171193004	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
REFIXIA 2000 UI POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Novo Nordisk A/S	1171193003	POLVO Y SOLUCIÓN PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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