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

Novo Nordisk A/S 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.

Momentum11.06

Growth78.01

Quality94.12

Value7.14

Short

Medium

Long