The following is an excerpt from a press release published by Novo Nordisk.
Novo Nordisk announced that two clinical trials in the concizumab phase 3 programme (explorer7 and 8) and one clinical trial in the phase 2 programme (explorer5) have been paused. The three clinical trials were investigating concizumab prophylaxis treatment in haemophilia A and B patients regardless of inhibitor status. Consequently, no additional patients will be recruited, and further treatment of patients currently enrolled in the trials with concizumab will cease.
The decision is a result of the occurrence of non-fatal thrombotic events in three patients enrolled in the ongoing phase 3 programme. Novo Nordisk and an independent Data Monitoring Committee are currently assessing the relevance of the events to the continuation of the programme and no conclusions have yet been made.
“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, 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”.
To read the press release in full, click here.
