Rival Sanofi, Novo Nordisk Insulin Combinations Gain FDA Approval

The FDA late Monday approved Soliqua and Xultophy, the competing combinations of insulin and glucagon-like peptide-1 (GLP-1) receptor agonists that analysts predict could await a market of up to $1 billion to treat type 2 diabetes (T2D).

Sanofi announced the approval in a press release late Monday. Novo Nordisk followed with a release announcing its approval.

Studies presented this summer at the American Diabetes Association (ADA), have found that that the once-daily injections that combine of insulin and a GLP-1 offer superior glycemic control without the weight gain or increased risk of hypoglycemia seen when giving the individual treatments alone. Novo Nordisk’s GLP-1 component, liraglutide, has the additional edge of having been shown to have some cardiovascular benefits—those results were also presented in June at ADA.

Soliqua combines insulin glargine, Sanofi's mainstay Lantus, with lixisenatide, while Novo Nordisk's Xultophy combines its newer insulin Tresiba with liraglutide (Victoza), which has formulations to treat both type 2 diabetes and obesity.

The fierce rivalry between Sanofi and Novo Nordisk had been delayed when the FDA extended deadlines for both approvals, originally set for August and September, respectively. Sanofi paid $245 million to redeem a priority review voucher to jump ahead of Xultophy in the approval process, which seemed undone when the FDA first delayed its approval due to concerns over the design of the delivery device, not the product. Soliqua’s deadline was reset for Monday, while the decision on Xultophy comes ahead of its December deadline.

In its statement, Sanofi cited phase 3 studies of more than 1900 patients presented at ADA involving the combination of the manufacturer’s mainstay insulin glargine, sold as Lantus (100 units/mL), and lixisenatide. In the insulin intensification study, Soliqua produced lower A1C compared with Lantus alone, with a majority of 736 patients (55% vs 30%) reaching the ADA recommended glycemic target of less than 7% A1C at 30 weeks.

Besides hypoglycemia, side effects included nausea (10%), which is associated with early weeks of GLP-1 therapy, diarrhea (7%), nasopharyngitis (7%), and upper respiratory tract infection (5%).

“Sanofi continues to be a pioneer in developing diabetes therapies and in bringing forward new treatment options for the approximately 50% of patients whose blood sugar levels remain uncontrolled on daily basal insulin,” Elias Zerhouni, MD, president of Global Research and Development for Sanofi, said in the statement. “Soliqua 100/33 is an alternate new approach that can help adults living with type 2 diabetes uncontrolled on basal insulin or lixisenatide to reach their treatment goal.”

The combination therapy also received a favorable recommendation on November 10, 2016, from a key committee of the European Medicines Agency. In the United States, it was approved by an FDA advisory panel 12-2 back in May, despite the concerns about the design of the pen used to deliver the drug. Xultophy is already available in Europe.

Xultophy’s approval is based on trial data involving 1393 adults that show patients with T2D inadequately controlled on liraglutide or basal insulin who switched to the combination therapy showed significant reductions in A1C from baseline of 1.67% and 1.94.% Adverse events included nasopharygitiis, headache, nausea, diarrhea, increased lipase, and upper respiratory tract infection.

Jakob Riis

"Novo Nordisk is committed to discovering and developing new medicines, like Xultophy 100/3.6, that may make a difference in the way some adults with type 2 diabetes manage their diabetes and achieve their treatment goals," said , executive vice president and head of North America Operations, Novo Nordisk A/S.

At least 27 million people in the United States and 400 million worldwide have T2D, and most who progress to old age with the disease will need insulin to treat it.