FDA Approves New Option for Type 2 Diabetes (Soliqua 100/33)

The FDA has approved Soliqua 100/33 (insulin glargine and lixisenatide injection) for the treatment of adults with type 2 diabetes that has been inadequately controlled with basal insulin or lixisenatide.

Soliqua 100/33 is delivered via single pre-filled pen for once-daily dosing. The safety and efficacy of the drug was examined in a Phase 3 program involving more than 1900 patients. In an insulin intensification study, Soliqua was associated with better HbA1c lowering than insulin glargine, with the majority of 736 patients achiving target HbA1c of  less than 7% at 30 weeks. Rates of hypoglycemia were similar among those taking Soliqua and with those taking insulin glargine alone.

The most frequent adverse events reported were hypoglycemia, nausea, nasopharyngitis, diarrhea, and upper respiratory tract infection.

—Michael Potts

Reference:

Sanofi. Sanofi receives FDA approval of Soliqua™ 100/33 for the treatment of adults with type 2 diabetes [press release]. http://www.news.sanofi.us/2016-11-21-Sanofi-Receives-FDA-Approval-of-Soliqua-100-33-for-the-Treatment-of-Adults-with-Type-2-Diabetes. November 21, 2016.