ANOTHER STUDY: Danish drugmaker Novo Nordisk said that U.S. regulators need to see data from a new study that evaluates cardiovascular health before they can finish reviewing the diabetes treatments Tresiba and Ryzodeg for approval.
THE CONSEQUENCE: Novo Nordisk submitted the drugs for U.S. approval in September 2011. Another study could delay a decision from the U.S. Food and Drug Administration for several years.
THE DRUGS: Tresiba and Ryzodeg both use the long-acting insulin degludec, which can help diabetics control their blood sugar levels beyond the 24-hour period offered by current products on the market. European regulators approved the drugs last month.
- Pharmaceuticals & Drug Trials
- Novo Nordisk