FDA Approves Expanded Label for Sanofi's Soliqua

The U.S. Food and Drug Administration (FDA) has approved the use of Sanofi’s Soliqua 100/33 (insulin glargine and lixisenatide injection) 100 U/mL and 33 mcg/mL for adults with uncontrolled Type 2 diabetes on oral antidiabetic medicines.

Soliqua was previously approved as an add-on to diet and exercise in adults with Type 2 diabetes uncontrolled on long-acting insulin or lixisenatide.

“Many people living with Type 2 diabetes are uncontrolled on diet and exercise alone and could require additional interventions to help lower their blood sugar levels,” said Michelle Carnahan, North America Head of Primary Care, Sanofi.

“This FDA decision marks the first combination insulin and GLP-1 injectable medicine approved for adults living with Type 2 diabetes who are uncontrolled with diet and exercise, potentially providing them access to an option that can help them achieve their treatment goals,” she said.

The FDA approval was based on data from the LixiLan-O clinical trial which showed, in adults with Type 2 diabetes uncontrolled with metformin and/or a second oral antidiabetic therapy, that treatment with Soliqua 100/33 led to significantly greater reductions in blood sugar levels compared with insulin glargine and lixisenatide.

In addition, significantly more patients reached their target blood sugar levels with Soliqua 100/33 (74%) compared with insulin glargine (59%) or lixisenatide (33%). Low blood sugar events were similar between Soliqua 100/33 (25.6%) and insulin glargine (23.6%), but were lower with lixisenatide (6.4%). The most common adverse events generally at the beginning of treatment in the Soliqua 100/33 arm were nausea (9.6%) and vomiting (3.2%).

Sanofi will continue offering its savings program for Soliqua 100/33 which can limit out-of-pocket expenses sometimes to $0 for all commercially insured patients regardless of formulary status on an insurance plan or income level.

For more information about this program, visit www.soliqua100-33.com. View the full press release here.