Novo Nordisk has withdrawn its application to extend the approved uses of its clotting factor NovoSeven to include the treatment of intracerebral haemorrhage, a form of stroke.
Last October, Novo Nordisk filed an application to extend the labelling of the drug to include the treatment of acute intracerebral haemorrhage in adults.
But the EU’s Committee for Medicinal Products for Human Use (CHMP) asked for additional safety and efficacy data before it would recommend the new use, and Novo Nordisk has decided to withdraw the current dossier and re-submit an application upon completion of an ongoing clinical study.
One factor believed to be behind the CHMP’s decision to ask for more safety data is a link between NovoSeven and a number of deaths arising from clotting side effects since its launch, which were highlighted in a study published in the Journal of the American Medical Association in January. This found that found that a disproportionate number of the cases were in cases where the drug was used off-label for treating conditions such as intracerebral haemorrhage.
NovoSeven (human recombinant coagulation Factor VIIa) has been approved in the European Union since1996 for the treatment of bleeding episodes and prevention of bleeding during surgery or invasive procedures in patients with certain blood-clotting disorders, including haemophilia.
NovoSeven is a major earner for Novo Nordisk, bringing in 5.1 billion kroner ($790m) in 2005, a rise of 16% on 2004 and accounting for around 15% of total group sales. The company said earlier that growth of the product last year had been ‘positively impacted’ by use in investigational settings.