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FDA rejects Novo’s Tresiba
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RegulatoryDenmark

FDA rejects Novo’s Tresiba

13.02.2013 - The FDA has rejected market authorization of Novo Nordisk’s long-acting insulin Tresiba and demands a complete new cardiovascular safety study.

The FDA asked the Danish insulin-maker to complete a cardiovascular safety study of the long-acting insulin in 7,500 patients before granting market authorisation. The decision on Tresiba comes just a few weeks after the European Medicines Agency had given the green light for the once daily insulin degludec.

 The move of the US regulatory agency came somehow unexpected after its endocrinologics and metabolic drugs advisory panel overcame its initial doubts over the increased risk of stroke and heart attacks and said it would accept a post-marketing study on cardiovascular risk. 

Most analysts don't expect Novo to have databefore 2016, offering market leader Sanofi more years to sell its blockbuster Lantus without a challenge from Tresiba. Sanofi made about 20% of its revenues with Lantus (US$6.6bn) last year – more than 50% of the global diabetes market. The FDA's complete response letter also caught Novo's related Ryzodeg in the regulatory net, which was also backed by the expert panel.

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