Novo Nordiskâ€™s Xultophy combines a previously marketed basal insulin with a glucagon-like peptide-1 receptor agonist, and was yesterday accepted by the FDA. The company plans to have the drug on the market in 2017.
In a press release yesterday, Novo Nordisk announced the Food and Drug Administration’s approval of their New Drug Application for Xultophy 100/3.6. A combination of two existing drugs, the company says Xultophy is intended as an adjunct to proper exercise and diet control to improve glycemic control in adult patients with type 2 diabetes.
The press release states that Xultophy “enters into a new class of diabetes treatments” because it combines basal insulin (Tresiba) and liraglutide (Victoza), a glucagon-like peptide-1 receptor agonist, into a single injection.
The drug’s effectiveness and safety were determined in a series of trials that encompassed nearly 1,400 type 2 diabetes patients whose diseases were uncontrolled on one of the two component treatments independently. The trials showed the drug effective in lowering A1C levels, particularly in those who had previously been on a basal insulin treatment alone. Adverse events included nasopharyngitis, headache, nausea, diarrhea, increased lipase, and upper respiratory tract infection.
The maximum daily dose of Xultophy corresponds to 50 units of insulin degludec and 1.8 mg of liraglutide, delivered in a pre-filled pen.
Tresiba was approved last year, and the combined project has been in the works for the years, with investigators claiming in 2014 that “nausea and other gastrointestinal side effects associated with liraglutide were reduced dramatically by the slow titration of the combination drug.”
Novo Nordisk plans to bring Xultophy to market “in the first half of 2017.”