Novo Nordisk has been hit by a report in the Journal of the American Medical Association implicating its haemophilia treatment, NovoSeven (recombinant human coagulation factor VIIa), in 67 deaths since its launch in 1999.
The JAMA report looked at how many cases of clotting side effects occurred since NovoSeven reached the market, and found that a disproportionate number were in patients without haemophilia, in other words cases where the drug was used off-label for treating conditions such as intracerebral haemorrhage.
Labelling for NovoSeven was updated to include information on the increased risk of thromboembolic side effects earlier this month, and Novo Nordisk said the data published in JAMA was not new, and that more information is needed before a direct link can be established.
However, the firm agreed that additional clinical testing should be carried out before NovoSeven is used outside of its approved indications of haemophilia A and B.
The company is developing the drug in Phase III testing as a treatment for intracerebral haemorrhage, and recently started a pivotal trial programme of the drug in the treatment of trauma patients. It remains to be seen if the side effect issue has any impact on the company’s efforts to expand the indications for NovoSeven outside haemophilia.
NovoSeven is a major earner for Novo Nordisk, bringing in 3.67 billion kroner ($670m) in the first nine months of 2005. Use in investigational settings “positively affected” the growth of the product, said the firm in its third-quarter results statement.