Soliqua®  100/33/ Suliqua®

Branded products in diabetes care commercialized by Sanofi under an exclusive worldwide license.

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Soliqua®  100/33/ Suliqua®

Soliqua100/33 / Suliqua is one of the first combinations of a GLP-1 analog and basal insulin to treat type 2 diabetes to be approved for marketing and launched for sale in the United States and is one of only two products (the other being Novo Nordisk’s Xultophy, which is a combination of its GLP-1 analog Victoza and basal insulin Tresiba) in this new product class.

Soliqua®  100/33 in the U.S.

On 21 November, Sanofi received U.S. Food and Drug Administration (FDA) approval for Soliqua®  100/33. Launched and available in U.S. retail pharmacies in January 2017.

Soliqua®  100/33 is a combination of lixisenatide.and insulin glargine
(Lantus®) and a GLP-1 receptor agonist, in a once-daily injection marketed
in the US by Sanofi. This product has been approved in the EU as Suliqua®
for type 2 patients. Soliqua®  100/33 has been approved in the U.S. indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (with a daily dose range from 15 to 60 Units) or lixisenatide. Soliqua®  100/33 is marketed in the U.S. by Sanofi.

Soliqua®  100/33 is delivered in the U.S. in a single pre-filled pen for once-daily
dosing using SoloSTAR® technology, the most frequently used disposable insulin
injection pen in the world.

Suliqua® in the EU

Suliqua®  was approved in the EU in january 2017 for type 2 patients for use in combination with metformin 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. Suliqua®  will be marketed in the
EU by Sanofi and is launched in May 2017 in the Netherlands.

Suliqua®  will be delivered in two prefilled SoloSTAR® pens, providing different
dosing options that may help answer individual market and patient insulin
needs.


Clinical trials

Soliqua™ 100/33 / Suliqua™ was formerly referred to as LixiLan (or iGlarLixi). The Phase 3 program was therefore conducted with the name LixiLan. The pivotal Phase 3 development program for LixiLan was comprised of two trials; LixiLan-O (1,170 adults with Type 2 diabetes) and LixiLan-L (736 adults with Type 2 diabetes). Both trials was completed in 2015.

Results of LixiLan-O

LixiLan-O investigated the efficacy and safety of a once-daily single injection of iGlarLixi, the titratable fixed-ratio combination of Lantus® (insulin glargine 100 Units/mL) and lixisenatide versus treatment with either lixisenatide or Lantus® alone over a 30 week period. The trial included 1,170 patients whose type 2 diabetes was not adequately controlled on metformin alone or on metformin combined with a second oral anti-diabetic agent. Treatment with metformin was continued for all participants throughout the study while other oral agents were discontinued.

After 30 weeks, iGlarLixi showed significantly greater reductions in HbA1c from baseline (8.1%) vs Lantus® and lixisenatide (-1.6%, -1.3%, -0.9%, respectively; p<0.0001), with patients reaching mean HbA1c levels of 6.5%, 6.8%, 7.3%, respectively. More patients reached target HbA1c <7% with iGlarLixi (74%) vs Lantus® (59%) or lixisenatide (33%). Mean body weight increased with Lantus® (+1.1kg), and decreased with iGlarLixi (-0.3kg; difference 1.4kg, p<0.0001) and with lixisenatide (-2.3kg).

Documented (≤70 mg/dL) symptomatic hypoglycemia was similar with iGlarLixi (25.6% of patients; 1.44 events/year (E/Y)) and Lantus® (23.6% of patients; 1.22 E/Y), but lower with lixisenatide (6.4% of patients; 0.34 E/Y). With iGlarLixi, 9.6% of participants experienced nausea and 3.2% experienced vomiting; with Lantus®, 3.6% of participants experienced nausea and 1.5% experienced vomiting; and with lixisenatide 24.0% of participants experienced nausea and 6.4% experienced vomiting.


Results of LixiLan-L

LixiLan-L investigated the efficacy and safety of a once-daily single injection of iGlarLixi, the titratable fixed-ratio combination of Lantus® (insulin glargine 100 Units/mL) and lixisenatide versus treatment with Lantus® over a 30 week period. The trial included 736 patients whose type 2 diabetes was not adequately controlled at screening on basal insulin, alone or combined with one to two oral anti-diabetic agents. Treatment with metformin, if previously taken, was continued throughout the study while other oral agents were discontinued.

After 30 weeks, iGlarLixi showed significantly greater reductions in HbA1c from baseline (8.1%) versus Lantus® (-1.1% vs. -0.6%; p<0.0001), with patients reaching mean HbA1c levels of 6.9% and 7.5%, respectively. More patients reached target HbA1c <7% with iGlarLixi (55%) versus Lantus® (30%; p<0.0001). Mean body weight increased with Lantus® (+0.7 kg), and decreased with iGlarLixi (-0.7 kg; difference 1.4 kg, p<0.0001).

Documented (≤70 mg/dL) symptomatic hypoglycemia was similar with iGlarLixi (40% of patients; 3.0 events/year (E/Y)) and Lantus® (42.5% of patients; 4.2 E/Y). With iGlarLixi, 10.4% of participants experienced nausea, and 3.6% experienced vomiting; while with Lantus® 0.5% of participants experienced nausea and 0.5% experienced vomiting.


Results from a clinical phase 2b trial of lixilan

Sanofi has evaluated LixiLan in a Phase 2b trial involving 323 patients with Type 2 diabetes insufficiently controlled on oral anti-diabetes medication (OADs) and with insulin glargine (Lantus®) as an active comparator.

Results from the Phase 2b trial were presented at both ADA 2014 and ADA 2015. In the trial, LixiLan (a fixed-ratio single-injection combination of lixisenatide and insulin glargine (Lantus®) (2 units glargine/1 mcg lixisenatide) gave a robust HbA1c reduction with weight loss and no increased hypoglycemia versus Lantus® and with very low gastro-intestinal adverse events in Type 2 diabetes patients inadequately controlled on metformin.

Results from Phase 2b trial showed a HbA1c lowering to 6.3 % and a weight loos of 1.2 kg for patients insufficiently controlled on insulin. Moreover, results showed no additional incidences of hypoglycemia compared to Lantus® as well as less frequent nausea and vomiting compared to what has been reported for the GLP-1 rapid acting class.