Safety issues force Novo Nordisk to shutter PhIII hemophilia trials
Five months after rolling out proof-of-concept data on their anti-tissue factor pathway inhibitor concizumab, Novo Nordisk abruptly shut down a trio of advanced clinical trials in the wake of serious safety issues.
The pharma company slammed the brakes on the three trials involving hemophilia A and B patients — 2 Phase IIIs and 1 Phase II — regardless of inhibitor status after 3 patients in the pivotal program experienced non-fatal thrombotic events, or blood clots.
Hemophilia drugs are designed to prevent uncontrolled bleeding among patients.
“While it is disappointing to pause the trials, patient safety is of utmost importance to Novo Nordisk – both for those taking part in our clinical trials and those who use our products on a daily basis,” said Mads Krogsgaard Thomsen, EVP and CSO of Novo Nordisk. “Together with relevant authorities, we will now carefully evaluate all available data and decide how to best move forward.”
Novo Nordisk was looking to come up with a rival for Roche’s powerhouse Hemlibra, which has been carving up the hemophilia market ahead of the arrival of some promising gene therapies.