After observing blood clots in some patients enrolled in clinical trials of concizumab, Novo Nordisk has paused one mid-stage and two late-stage studies of its hemophilia drug.
The phase III trials explorer 7 and 8 and the phase II study explorer 5 were evaluating concizumab as a prophylactic treatment for patients with hemophilia A and B regardless of inhibitor status. The decision to end the trial comes after 3 patients experienced non-fatal thrombotic events.
“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, PhD, Executive Vice President and Chief Science Officer of Novo Nordisk. “Together with relevant authorities, we will now carefully evaluate all available data and decide how to best move forward.”