The US Food and Drug Administration (FDA) has approved two new competing combination products containing fixed doses of glucagonlike-peptide 1 (GLP-1) receptor agonists and long-acting insulins, from Sanofi and Novo Nordisk respectively, for the treatment of adults with type 2 diabetes.
Both products, known as LixiLan and IDegLira during clinical trials, were delayed by 3 months at the FDA following recommendations for approval from FDA panels back in May.
Now the approval in the United States for the Sanofi product, LixiLan, is the first market worldwide for this combination of its GLP-1 receptor agonist lixisenatide (Lyxumia/Adlyxin) and insulin glargine (Lantus). It is indicated for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 units a day) or lixisenatide.
To be known as Soliqua 100/33, the prefilled pen device contains a fixed dose of insulin glargine 100 U/mL and lixisenatide 33 µg/mL and is indicated for once-daily dosing covering 15 to 60 units of insulin glargine and 5 to 20 µg of lixisenatide.
The pen uses SoloStar technology, the most frequently used disposable insulin-injection platform in the world, according to Sanofi.
Soliqua 100/33 will be available in retail pharmacies in the United States in January 2017.
Similarly, the Novo Nordisk product is a fixed-dose combination of 100/3.6 of insulin degludec (Tresiba) and the GLP-1 agonist liraglutide (Victoza). To be known as Xultophy, it is indicated once daily as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).
Xultophy 100/3.6 can be taken at the same time each day with or without food and will be available in a prefilled pen. It delivers doses from 10 to 50 units with each injection, and each unit of Xultophy 100/3.6 contains 1 unit of insulin degludec and 0.036 mg of liraglutide. The starting dose is 16 units (16-units insulin degludec and 0.58-mg liraglutide), and the maximum dose of 50 units corresponds to 50 units of insulin degludec and 1.8 mg of liraglutide.
Launch in the United States is anticipated in the first half of 2017, says Novo Nordisk.
"Novo Nordisk will work diligently to secure access for Xultophy 100/3.6 on health plans nationwide and is committed to ensuring that [the product] is accessible and affordable for all appropriate patients. Novo Nordisk will also offer a savings card that will allow eligible patients with commercial insurance to reduce their copay," it says.
Industry analysts expect Xultophy to generate annual sales of around $1.2 billion in 2021, while Soliqua is forecast to reach $550 million by then, according to consensus estimates compiled by Thomson Reuters.
Xultophy Already Marketed in European Union; Sanofi Product Soon Will Be
The European Medicines Agency (EMA) has also just given the green light to Sanofi's combination of insulin glargine and lixisenatide; it is likely to be formally approved in the European Union within a couple of months, where it will be known as Suliqua, with a slightly different choice of doses (insulin glargine 100 U/mL with lixisenatide 33 or 50 µg/mL).
The indication in the European Union also differs slightly — there Suliqua will be indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose-lowering medicinal product or with basal insulin.
The Novo Nordisk product, Xultophy, is already available in the European Union — similarly, it is indicated there to improve glycemic control in combination with oral glucose-lowering medicinal products when these alone or combined with basal insulin do not provide adequate glycemic control.