Danish insulin giant Novo Nordisk (NOV: N) says that it has decided to discontinue the development of vatreptacog alfa, a fast-acting recombinant factor VIIa analogue for hemophilia patients with inhibitors.
The decision follows analysis of the data from the Phase III a trial adept 2. On August 9, Novo Nordisk announced that a few patients in the trial had developed anti-drug antibodies to vatreptacog alfa, one patient with a potentially neutralizing effect. Coincidentally, on the same day, the company gained orphan drug designation for the product from the European Commission for the treatment of haemophilia A.
In the blinded adept 2 trial, 72 hemophilia patients with inhibitors were treated. Patients were treated on demand with either vatreptacog alfa or NovoSeven (eptacog alfa) in random sequence as bleedings occurred. In total, 567 bleeding episodes were treated. NovoSeven, a recombinant Factor VIIa, generated first-half 2012 sales of7.36 billion kroner ($759.6 million), a 5% rise on the like 2011 period.
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