FDA Approves Combination Diabetes Drug

The FDA recently approved Soliqua 100/33 (insulin glargine & lixisenatide injection) for the treatment of patients with type 2 diabetes whose disease is not well-controlled with insulin or lixisenatide monotherapy.

Soliqua 100/33 is a combination treatment of Lantus (insulin glargine 100 units/mL) plus lixisenatide, a GLP-1 receptor antagonist, which may improve blood glucose control when used along with diet and exercise, according to a press release from Sanofi.

Sanofi expects that the drug will be available for purchase in the United States in January 2017.

The new approval is based on positive findings from a phase 3 clinical program that included more than 1900 patients whose disease was inadequately-controlled by basal insulin or lixisenatide. Investigators found that Soliqua 100/33 exhibited the ability to lower HbA1c more significantly than Lantus.

In 55% of patients taking Soliqua 100/33 achieved the American Diabetes Association target of less than 7% at 30 weeks, compared with 30% of patients taking Lantus, according to Sanofi. Both groups of patients experienced similar rates of hypoglycemia.

Common adverse events included hypoglycemia, nausea, nasopharyngitis, diarrhea, and upper respiratory tract infection. Other more serious adverse events include allergic reactions, hypokalemia, and heart failure.

Soliqua 100/33 should not be taken along with other GLP-1 receptor antagonists, and should also not be taken by patients with type 1 diabetes, diabetic ketoacidosis, or gastroparesis.

Only 60 units of Soliqua 100/30 should be taken per day, as patients may experience nausea and vomiting if additional units are administered.

It is also unknown whether the drug is safe in patients under 18-years-old, and should not be used among this group. Sanofi also warns that the injection pen should not be shared with others, even if the needle has been changed, since it may result in a serious infection.

Soliqua 100/33 has also been submitted for regulatory review in 10 markets, including the European Union. The Committee for Medicinal Products for Human Use of the European Medicines Agency previously issued a positive opinion about the drug, according to Sanofi.

Thus far, Soliqua 100/33 has not been approved outside of the United States.

“Sanofi continues to be a pioneer in developing diabetes therapies and in bringing forward new treatment options for the approximately 50 percent of patients whose blood sugar levels remain uncontrolled on daily basal insulin,” said Elias Zerhouni, MD, president of Global R&D at Sanofi. “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.”