Insulin glargine + lixisenatide

36630811000001108

New Medicines

Suliqua (EU), Soliqua (US) · Type 2 diabetes mellitus in adults

Information

Suliqua (EU), Soliqua (US)
New formulation
Sanofi
Sanofi

Development and Regulatory status

Launched
Launched
Launched
May 2019

May 19: Launched in the UK. Price: 100iu/33 microgram per ml, 3 x 3ml SoloStar pre-filled pen=£51.30. 100iu/50 microgram per ml, 3 x 3ml SoloStar pre-filled pen=£67.50 [24].


May 17: Launched in Netherlands and Austria [22].


Jan 17. Approved in the EU [21]


Jan 17: Launched in the US at a list price of $127 for a 300-unit pen [20].


Nov 16: Soliqua will be priced on par with solo GLP1s in the US [19].


Nov 16: Approved in US [18].


Nov 16: EU positive opinion for use in combination with metformin for treatment of adults with type 2 diabetes mellitus to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin [17].


Aug 16: FDA demands more information on the drug delivery device, pushing back the PDUFA date by 3 months to end of November and nearly wiping out the time Sanofi saved by redeeming a $245 million (€216 million) priority review voucher [14].


May 16: FDA panel votes 12 to 2 in favour of approving iGlarLixi [10].


Apr 16: Filed in the EU via the centralised procedure [9].


Mar 16: EU filing expected Q1 16 [8].


Dec 15: Sanofi redeemed an outstanding priority review voucher, which shortens the standard FDA review time for submitted drugs from 10 months to 6 months and will begin once the agency accepts the application [7].


Dec 15: Filed in the US [7].


Jul 15: Regulatory submissions are planned for Q4 2015 in the United States and Q1 2016 in the European Union. [5]

Category

Glucagon like peptide 1 receptor agonist + long acting insulin
ECurrently 3.8 million people in the UK are diagnosed with diabetes (90% type 2), and it is estimated that a further 1 million people with type 2 diabetes have not yet been diagnosed [23].
Type 2 diabetes mellitus in adults
Subcutaneous

Trial or other data

Sep 19: PIII LixiLan-G RCT (n=514) is published; the study found that switching to insulin glargine plus lixisenatide (IG+LX) improves HbA1c vs continued GLP-1 monotherapy (-0.6%, p<0.0001). More IG+LX patients achieved HbA1c <7% (62% vs 26%, p<0.0001). Nausea, vomiting and hypoglycaemia rates were higher with IG+LX [26].


Jun 19: Positive outcome data from PIII LixiLan-G study (n=514) showed that pts switched to Soliqua demonstrated a statistically superior reduction of HbA1c after 26 weeks [- 1.02%] vs. continuing a daily or weekly GLP-1 treatment plus metformin (with or without pioglitazone and an SGLT2 inhibitor) [-0.38%, p<0.0001]. Pts were randomised to either switch to Soliqua or continue their previous GLP-1 treatment, while maintaining their other pre-trial anti-diabetic medication. The PIII study evaluated adults with type 2 diabetes inadequately controlled by GLP-1 treatments. The study showed a safety profile consistent with the established profiles of the treatments studied: the most common classes of adverse event were gastrointestinal events (i.e., nausea, diarrhea and or vomiting) and hypoglycemia. [25]


Sep 16: Results of LixiLAN-L published online in Diabetes Care. Study (n=736) found combination insulin glargine+lixisenatide showed greater reductions in HbA1c vs insulin glargine alone at 30 weeks (–1.1% vs –0.6%, p<0.0001). Mean body weight decreased by 0.7kg with combination and increased by 0.7kg with insulin glargine (p< 0.0001) [16].


Aug 16: Results of LixiLan published online in Diabetes Care. Study (n= 323) found at week 24, mean HbA1c was reduced from 8% to 6.3% and 6.5% with LixiLan and insulin glargine, respectively, establishing noninferiority and superiority of LixiLan. Body weight reduced with LixiLan (–1 kg) and increased with insulin (+0.5 kg; p< 0.0001) [15].


Aug 16: In 1,170 diabetic people (LixiLan-O study) on metformin randomised to fixed-ratio combination of insulin glargine (iGlar) and lixisenatide (Lixi) vs. individual components alone, more subjects reached target HbA1c <7% with iGlarLixi (74%) versus iGlar (59%) or Lixi (33%) (P<0.0001 for all) [13].


Jun 16: Sanofi announces pivotal PIII LixiLan-O and LixiLan-L trials both met their primary endpoints, demonstrating statistically superior reduction of HbA1c with the titratable fixed-ratio combination versus comparators (lixisenatide and insulin glargine 100 Units/mL, respectively). The most frequent adverse events were nausea, vomiting and diarrhoea [12].


Sept 15: Sanofi announced today that the LixiLan-L PIII clinical trial (NCT02058160) met its primary endpoint (change in HbA1c from baseline to wk 30) in 736 pts with type 2 diabetes treated with insulin glargine with or without metformin. LixiLan demonstrated statistically superior reduction in HbA1c vs. insulin glargine 100 Units/mL. The safety profile of LixiLan reflects that of insulin glargine 100 Units/mL and lixisenatide [6]


Jul 15: LixiLan-O trial has met its primary endpoint; LixiLan showed a statistically superior reduction in HbA1c (three months average blood glucose) compared with lixisenatide and compared with insulin glargine 100 units/mL. Overall, LixiLan had a safety profile similar to those of lixisenatide and insulin glargine 100 units/mL. [5]


Feb 14: NCT02058160 (LixiLan-L) is a PIII randomized, 30-week, active-controlled, open label, 2- treatment arm, multicentre study insulin glargine/lixisenatide fixed ratio combination to insulin glargine with or without metformin in 700 patients with T2DM. The primary outcome is change in HbA1c from baseline to week 30. The study starts Feb 14 and is due to complete Aug 15 [4].


Feb 14: NCT02058147 (LixiLan-O) is a PIII randomized, 30 week, active-controlled, open-label, 3-treatment arm, multicentre study comparing insulin glargine/ lixisenatide fixed ratio combination to insulin glargine and to lixisenatide alone on top of metformin in 1125 patients with T2DM. The primary outcome is change in HbA1c from baseline to week 30. The study starts Feb 14 and is due to complete Aug 15 [4].


Feb 14: Clinical Phase III development programme for LixiLan has been started. [3]


Sept 13: Phase III clinical development of lixisenatide/insulin glargine will begin in the first half of 2014. [2]


LixLan is a fixed-ratio combination of lixisenatide/insulin glargine, administered via the Tactipen® device. [2]