- Although the FDA rejected Novo's long-acting insulin Tresiba (insulin degludec) in 2013, the company hopes to have it on the US market by 2016.
- The FDA was concerned about potential Tresiba-related cardiovascular risks.
- Novo has accumulated interim data on Tresiba from the DEVOTE trial, which specifically looks at CVD safety and risks. The company is planning to submit analysis of the interim data to the FDA within the next month.
Novo notes that the interim data that it is submitting to the FDA is only an indication of the final trial results. While the FDA may accept the filing, there is also the possibility that it will issue an incomplete response letter.
Concerns about higher rates of heart attacks or strokes have not kept Tresiba out of some markets in the EU, and US regulators are looking closely at the DEVOTE data to determine whether the risk is manageable. Overall, the five-year outlook for Tresiba is good, with industry analysts predicting $2.2 billion in sales by 2020.