With New Phase 3 Data From Its Hemophilia Study, Novo Nordisk Plots Route To FDA

Novo Nordisk A/S (NYSE:NVO) announced the phase 3 results of the explorer7 study, assessing the efficacy and safety of prophylactic treatment…
  • Novo Nordisk A/S (NYSE:NVO) announced the phase 3 results of the explorer7 study, assessing the efficacy and safety of prophylactic treatment with concizumab in people with hemophilia A or B with inhibitors.
  • Concizumab achieved its primary goal, reducing spontaneous and traumatic bleeds by 86% in a prophylactic setting compared to a control arm. 
  • In March 2020, Novo Nordisk halted two Phase 3 studies and one Phase 2 trial after three patients experienced non-fatal blood clots. The FDA also placed the program on clinical hold.
  • But Novo restarted development after finding a “new path forward” in August 2020. 
  • Researchers tested the drug in 133 boys and men aged 12 and over.
  • In the prophylaxis arm, the estimated average annualized bleeding rate (ABR) was 1.7, while in the non-prophylaxis arm, the average ABR was 11.8. 
  • Additionally, the overall median ABR of concizumab was zero, compared to 9.8 for no prophylaxis.
  • The safety and tolerability profile of concizumab was within the expected range, with no thromboembolic events reported after treatment restart.
  • Novo Nordisk expects to submit a marketing application in 2H of 2022 in the U.S. and Japan and 2023 in the EU and the U.K.
  • Price Action: NVO shares are up 1.08% at $110.21 during the market session on the last check Monday.
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