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Novo Nordisk’s GLP-1/insulin combination, Xultophy, Moves One Step Closer to Approval in Europe

Twitter Summary: Novo Nordisk’s Xultophy gets positive recommendation in Europe, full approval to hopefully come soon!

On July 25, Novo Nordisk announced that the European Medicines Agency had given a positive recommendation for IDegLira, a combination of Tresiba (long-acting basal insulin degludec) and Victoza (GLP-1 agonist liraglutide). While this announcement doesn’t automatically secure IDegLira’s European approval, it definitely brings it one step closer to market. If approved, the drug should be available in Europe within the first half of 2015 under the brand name Xultophy.

Xultophy will be a once-daily injection taken independently of mealtimes. The combination therapy merges the blood glucose lowering effects of using Tresiba or Victoza alone, while Victoza’s weight loss advantages help counteract the weight gain typically seen with insulin. The promising trial results for Xultophy received a lot of attention from experts at last year’s ADA conference. Recent results demonstrated that participants with type 2 already on insulin who took Xultophy achieved an average A1c reduction of 1.9%, compared to a 0.9% reduction from taking Tresiba alone. Xultophy was also better than Tresiba alone in terms of weight – people treated with Xultophy had a mean weight loss of 2.7 kg (6 lbs) compared to no change in those on Tresiba. 

Despite impressive trial results, Xultophy has experienced difficulties in the US because of FDA concerns with the cardiovascular safety of Tresiba (the FDA rejected Tresiba in February 2013, further delaying the Xultophy combination). A cardiovascular safety trial is currently underway for Tresiba, and data for analysis may be ready earlier than expected so it can hopefully be resubmitted to the FDA in the first half of 2015. Xultophy has to hold out for Tresiba’s approval until it can be submitted to the FDA, but in the meantime its potential approval in Europe would be a huge win for patients there. -AJW

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