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Nonacog beta pegol

Generic Name
Nonacog beta pegol
Brand Names
Refixia
Drug Type
Biotech
CAS Number
1175512-71-6
Unique Ingredient Identifier
27Y83O992Q

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.

Background

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

FDA Approved Products

No FDA products found for this drug

Singapore Approved Products

No Singapore products found for this drug

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