Novo Eyes Global-First Japan Approval For Concizumab
First Filing For Hemophila A/B Candidate
Novo Nordisk has filed for the approval of its hemophilia A/B contender concizumab in Japan, which could become the first market globally for the TFPI inhibitor. The company sees dosing convenience as a potential strong advantage in the market, where there are relatively few options for hemophilia B available.
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Hemlibra receives new approval in Japan intractable disease indication, while positive Phase III results in mild/moderate disease hemophilia A will support a planned EU filing in this setting.
Sanofi/Sobi’s efanesoctocog is in line for US FDA action three months after CSL/uniQure’s gene therapy user fee goal, while BioMarin’s Roctavian resubmission and Novo Nordisk’s concizumab are waiting in the wings.
Phase III data for the drug showed strong efficacy among hemophilia A and B patients with inhibitors. The drug’s approval would help drive continued segmentation of the hemophilia market.