Novo Nordisk seeks expanded label for Tresiba
- Novo Nordisk has submitted a supplemental application to the Food and Drug Administration to add in cardiovascular data for its long-lasting basal insulin analog, Tresiba (insulin degludec).
- The data is from the long-term DEVOTE trial, which compared the cardiovascular safety of Tresiba with Sanofi's Lantus (insulin glargine) added to standard of care, and was used to support the DEVOTE interim analysis used as the basis of the 2015 approval of Tresiba.
- The primary endpoint, the non-inferiority of major adverse cardiovascular events (MACE), showed a similar reduction with Tresiba and Lantus, with a hazard ratio of 0.91 in favor of Tresiba, and no statistically significant difference. For the secondary endpoint, severe hypoglycemia, 27% fewer Tresiba patients had an episode of severe hypoglycemia, compared with Lantus, increasing to 54% during sleep.
This submission would allow Novo Nordisk to include data from the DEVOTE study, which measured cardiovascular safety and the effects on hypoglycemia.
This could have potential to grow the drug's market in type 2 diabetes. However, what remains to be seen is whether the FDA will consider the data sufficient. The agency has been strict with diabetes companies and typically does not consider hypoglycemia claims as major differentiators.
Tresiba, an ultralong-acting basal insulin analog, has been approved in the U.S. since September 2015, where it had a 5.5% share of the U.S. basal insulin market in 2016, but it hasn't managed to make major headway against the older drug Lantus. However, the sales of Tresiba are increasing. It has been launched in at least 52 countries, and accounted for 47% of Novo Nordisk's sales growth in 2016. Its sales grew to DKK 4,056 million ($607.9 million) in 2016, compared with DKK 1,270 million ($190.3 million) in 2015.
- Novo Nordisk Press release
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