The U.S. Food and Drug Administration (FDA) has expanded the label for insulin degludec to include information on cardiovascular outcomes and deceased severe hypoglycemia. Additionally, Samsung Bioepis Co. Ltd. and AbbVie Inc. have settled all patent litigation related to a biosimilar to adalimumab.
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DEVOTE Trial Details & Results
The FDA has approved an updated label for insulin degludec (Tresiba), a once-daily basal insulin that works for more than 42 hours and provides flat and stable glucose-lowering effects.1 The new labeling includes data for improved cardiovascular outcomes and decreased hypoglycemia from the DEVOTE trial.
DEVOTE, a 104-week, multinational, double-blind clinical trial, included Type 2 diabetic adults (N=7,637) with high cardiovascular risk. All study participants were inadequately controlled Type 2 diabetics with atherosclerotic cardiovascular disease. Patients were already receiving standard of care for cardiovascular risk reduction.
The study showed non-inferiority of insulin degludec compared with insulin glargine regarding major adverse cardiovascular events, which were defined as first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. The hazard ratio was 0.91. Additionally, insulin degludec led to a 40% lower rate of severe hypoglycemia, which was statistically significant, compared with insulin glargine at a pre-specified secondary endpoint. Glycemic control between the two groups was similar throughout the study and at baseline.
In 2017, the insulin degludec label in the European Union was updated with this outcome data.
Adalimumab Biosimilar Coming to Market
On April 5, Samsung Bioepis Co. Ltd. announced that it has settled all pending patent litigation with AbbVie Inc over the SB5 (Imraldi). Imraldi is biosimilar to AbbVie Inc.’s adalimumab (Humira). Imraldi is expected to be available in Europe in October 2018. If the agent receives FDA approval, it will be available in the U.S. in June 2023.2
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Novo Nordisk. News release: FDA approves inclusion of data on cardiovascular outcomes and severe hypoglycaemia in the Tresiba label. 2018 Mar 26.
- Samsung Bioepis. News release: Samsung Bioepis settles patent disputes with AbbVie, clearing the way for the commercialization of SB5 (adalimumab) in all approved markets worldwide. 2018 Apr 5.