Eli Lilly Gets US Approval and Novo Nordisk EU Approval for Respective Diabetes Drugs

Eli Lilly has received approval from the US Food and Drug Administration (FDA) for Trulicity (dulaglutide), an once-weekly, glucagon-like peptide-1 (GLP-1) receptor agonist, indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. It acts like GLP-1, a natural hormone, helping the body release its own insulin when patients eat.  

Eli Lilly plans to make Trulicity 0.75 mg and 1.5 mg single-dose pens available for adults in the United States later this year. The drug is also under review by the European Medicines Agency and other regulatory bodies.

In other news, ​Novo Nordisk received marketing approval from the European Commission for Xultophy for the treatment of Type 2 diabetes mellitus in adults. Xultophy is an once-daily, single-injection combination product consisting of Novo Nordisk’s Tresiba (insulin degludec), a once-daily basal insulin analog, and Novo Nordisk’s Victoza (liraglutide), an once-daily human GLP-1 analog.

Diabetes care is the largest product franchise for Novo Nordisk with 2013 revenues of DKK 65.5 billion ($11.3 billion). Of that total, insulins and protein-related therapeutics accounted for DKK 51. 6 billion ($8.9 billion). Victoza had 2013 sales of DKK 11.6 billion ($2.0 billion). On an industry level, the GLP-segment of the diabetes market represented approximately 6.9% of the diabetes market in 2013, according to estimates by Novo Nordisk.

Source: Eli Lilly and Novo Nordisk

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