Soliqua®Phase 3 results significantly lowered blood sugarlevels compared to GLP-1 receptor agonist treatmentsPatients switched to Soliqua reached anaverage blood sugarbelowthe American Diabetes Association recommendedlevel of 7%FullPhase 3 data presentedtodayat the American Diabetes Association(ADA)79th Scientific Sessions PARIS–June 9, 2019–In a Phase 3 study1evaluating adults with type 2 diabetes inadequately controlled by GLP-1 receptor agonist (GLP-1 RA) treatments, Soliqua®/Suliqua®2(insulin glargine 100 Units/mL and lixisenatide) met the primary study objectivebydemonstrating astatistically superior reduction of average blood sugar level (HbA1c)after26weeks, compared with continuing GLP-1 RA treatment.The LixiLan-G study included either a daily or once-weekly GLP-1 RA treatmentas comparator. Morepatientswho switched to Soliqua achieved HbA1clevelsbelow 7%, a target recommended by the ADA, compared with those who stayed on previous GLP-1 RA therapy. More patients who switched to Soliqua also achieved the composite endpoint of HbA1cbelow 7% without documented symptomatichypoglycemia(low blood sugar levels).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.1Blonde L et al, Presentation #149 OR, American Diabetes Association 79th Scientific Sessions, June 9, San Francisco, CA, U.S.2Soliqua®is an injectable prescription medicine that contains two diabetes medicines, insulin glargine and lixisenatide.Soliqua®is marketed in the EU as Suliqua®, where it is indicated in combination with metformin for the treatment of adults with type 2 diabetesmellitus to improve glycemic control when this has not been provided by metformin alone ormetformin combined with another oral glucose lowering medicinal product or with basal insulin. It is marketed in the U.S. as Soliqua®100/33, where it is indicatedas an adjunct to diet and exercise to improve glycemiccontrol in adults with type 2 diabetes mellitus.It is marketedas Soliqua®in other geographies where it is approved
The full Phase 3 data results were presented today for the first time as an oral presentation at the 79thScientific Sessions of theADAin San Francisco.“We are committed to providing people living with diabetes a broad range of options thatcan help support personalized care,”said Rachele Berria, Global Head of Diabetes Medical Affairs at Sanofi. “As the first comparison between Soliqua and both daily and weekly GLP-1 RA treatments, this study provides physicians with new data that they could use when consideringSoliqua as a part of a personalizedtreatment plan.”About the studyThe LixiLan-G study included 514 adults with type 2 diabetes who were inadequately controlled on a GLP-1 RA (either once-daily liraglutide or twice-daily exenatide, or once-weekly exenatide extended release, albiglutide or dulaglutide) and metformin (with or without pioglitazone, with or without a sodium-glucose transport protein 2 inhibitor [SGLT2i]).Participants were randomized to either switch to Soliqua or continue theirprevious GLP-1 RA treatment, while maintaining their other pre-trial anti-diabetic medication. Adherence to allocated treatment was monitored and reinforced throughout the study.The primary objective was to demonstrate superior reduction of HbA1cwith Soliqua versus continuation ofthe previousGLP-1 RA after 26 weeks. Secondary objectivesincludedcomparison of the overall efficacy and safety ofSoliqua to continued GLP-1 RA treatment. After 26 weeks, patients who switched to Soliqua saw a 0.6% greater reduction in HbA1cversus continuing treatment with a GLP-1RA:SoliquaGLP-1 RAMean HbA1cat baseline7.86%7.88%Mean HbA1cat Week 266.7%7.4%Reduction in HbA1c-1.02%-0.38%Least squares mean difference-0.64%95% Confidence interval-0.77to -0.51p-value<0.0001More patients who switched to Soliqua achieved HbA1cbelow the 7%target recommended by the ADAversus those treated with GLP-1RA(difference: 36%, p<0.0001).The study also evaluated compositetargets
of HbA1cbelow 7% without documented symptomatic hypoglycemia(<54mg/dL or ≤70mg/dL, respectively):SoliquaGLP-1 RA% of patientsachieving HbA1c< 7%62%26%% of patients achieving HbA1c<7% with no documented (≤70 mg/dL) symptomatic hypoglycemia43%25%% of patients achieving HbA1c<7% with no documented(<54 mg/dL) symptomatic hypoglycemia57%25%The study showed a safety profile consistent with previous studies:22% of patients who switched to Soliqua experienced gastrointestinal events (nausea, diarrheaor vomiting), compared with 10% of patients who continued previoustreatment with GLP-1 RA. Rates of hypoglycemiawere also consistent with the established safety profiles of thetreatments: 9% of patients who treated with Soliqua experienced at least one event, compared with <1% who remained on previous GLP-1 RA therapy.Participants treated with Soliqua were followed for a further 26 weeks. Data from this extension period will be presented at a later date.About SanofiSanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.Sanofi, Empowering LifeMedia Relations ContactAshleigh KossTel.: +1 908-981-8745Ashleigh.Koss@sanofi.comInvestor Relations ContactGeorge GrofikTel.: +33 (0)1 53 77 45 email@example.comSanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actualresults and developments to differ materially fromthose expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or
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