Novo Nordisk halts three haemophilia studies after participants suffer thrombotic events

pharmafile | March 17, 2020 | News story | Manufacturing and Production, Research and Development |  Novo Nordisk, haemophilia, pharma 

Novo Nordisk has moved to temporarily shut down two of its Phase 3 and one of its Phase 2 clinical studies into concizumab after it was discovered that three participants had suffered thrombotic events.

Fortunately, the events were non-fatal. The studies were investigating the drug for the preventative treatment of haemophilia A and B in patients regardless of inhibitor status.

The imposed halt on the studies means that no further participants will be recruited and all patients currently enrolled and receiving the therapy will no longer receive treatment. Novo Nordisk confirmed it was assessing the situation in partnership with an independent Data Monitoring Committee and will decide on whether to continue the research programme.

“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.”

Matt Fellows