Sanofi/Sobi’s Next-Gen Factor VIII Therapy BLA Heats Up Biotech-Driven Hemophilia Arms Race
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.
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Bountiful Approvals May Be Ahead As FDA Starts 2023 With Almost 60 Novel Agents Under Review
The upcoming year could see a rebound approvals if the bigger-than-usual queue of novel agents with 2023 user fee goal dates pans out.
November Gloom? US FDA’s Goal Dates Include Hard Calls On Ferring Rebyota, Y-mAbs’ Omblastys
November should see FDA action on what could be the first standardized fecal microbiota transplant product, rare cancer therapies from Y-mAbs and Spectrum, uniQure/CSL’s hemophilia B gene therapy and Provention Bio’s biologic to delay type 1 diabetes.
Novo Eyes Global-First Japan Approval For Concizumab
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.