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Novo Nordisk hemophilia B drug OK for EU

March 24, 2017

Novo Nordisk (NVO) announced that its hemophilia B drug, Refixia (nonacog beta pegol, N9-GP), has secured a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), for the treatment of adolescents and adults with hemophilia B.

Drug Recommended for both Prevention and Treatment

The recommendation includes the use of the drug to prevent the disease as well as on-demand treatment of bleeding and for surgical procedures in adolescent above 12 years of age, and in adults with hemophilia B (congenital factor IX deficiency). The CHMP’s recommendation is based on the positive outcomes of a Phase 3 trial in which 115 previously treated children and adults with hemophilia B were administered Refixia.

Refixia works as a drug substance for replacement therapy in patients with hemophilia B. Replacement therapy is a treatment aimed at making up a deficit of a substance normally present in the body.

Positive opinion by CHMP is usually the second-last step before the EMA grants a final approval for allowing the commercial launch of the drug in the large European region comprising of 28 member nations. Novo has two more hemophilia drug candidates: N8-GP (NN7088) in hemophilia A Phase 3 study, and Concizumab (NN7415) in hemophilia A and B Phase 1 trial.

Competitive Hemophilia Market

The global market for hemophilia drug is estimated to grow 5.6% annually between 2013 and 2024, and is expected to hit sales of $15.2 billion by 2024. However, competition is getting intense, as existing players like Bayer AG (BAYRY), Shire PLC (SHPG), and Novo Nordisk are continuing with their traditional factor replacement-based hemophilia drugs in addition to innovations.

New entrants like Biogen Inc.’s (BIIB) spin-off Bioverativ Inc. (BIVV), is set to offer stiff competition with its long-lasting new-age treatments.


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