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UPDATE: Lexicon Announces FDA Approval of INPEFA™ (sotagliflozin) for Treatment of Heart Failure
2023-06-15
上市批准临床3期临床结果AHA会议
UPDATE: Lexicon Announces FDA Approval of INPEFA™ (sotagliflozin) for Treatment of Heart Failure
INPEFA reduced the risk of total occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits by 33% compared to placebo in the SOLOIST-WHF study
Conference Call and Webcast on Tuesday, May 30, 2023, at 8:00 am Eastern Time
A Media Snippet accompanying this announcement is available by clicking on the image or link below:
PDF available: http://ml.globenewswire.com/Resource/Download/78db7a8c-bdce-44a2-80fb-a7d2be46305e
THE WOODLANDS, Texas, June 15, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (FDA) has approved INPEFA™ (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:
heart failurees mellitus, chronic kidney disease, and other cardiovascular risk factors.
type 2 diabetes mellitussechronic kidney diseasets across the full range of left ventricular ejection fraction (LVEF), including preserved ejection fraction and reduced ejection fraction, and for patients with or without diabetes.
“The approval of INPEFA alonheart failureeadth of the label, is a major milestone in Lexicon’s path to fulfilling its mission of pioneering medicines that transform patients’ lives,” said Lonnel Coats, Lexicon’s chief exediabetesfficer. “We expect this important innovation to be commercially available in the U.S. market by the end of June 2023.”
The approval is bINPEFAn two randomized, double-blind, placebo-controlled Phase 3 carLexiconular outcomes studies of INPEFA in patients with heart failure or at risk of heart failure. Together, SOLOIST-Lexiconrsening Heart Failure) and SCORED enrolled almost 12,000 patients. Results from SOLOIST-WHF showed that INPEFA significantly reduced risk of the composite of hospitalizations for heart failure, urgent visits for heart failure, and cardiovascular death by 33% compared to placebo in patients who had been recently hospitalized for worsening heart failure.
INPEFA is an inhibitor of both sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1). The SGLT inhibitor clINPEFAs recommended as fheart failureatment for hearheart failurethe American Heart Association (AHAHeart Failurean College of Cardiology (ACC), and the Heart Failure Society of America (HFSA) in INPEFAjoint 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failureheart failure23 ACC expert consenheart failure highlighted the benefit of SGLT inhibitors as part of Guideline-Directed Medical Therapy (GDMT) in patients with hheart failurewith preserved ejection fraction (HFpEF). According to the ACC expert consensus statement, SGLT2 inhibitors should be initiated in all individuals with HFpEF who are stable during hospitalization and have no patient population contraindications.
INPEFA6.7 million Americans suffer from heart failure, with the prevalence expected to rise to 8.0 mSGLT inhibitor. Heart failure is the leading cause of hospitalizaheart failureividuals aged 65 and older, triggering approximately 1.3 million hospitalizations a year. PaHeart Failureeart failure are at highest risk of a heart failure event in the first 30 days post-dischargHeart Failureing and 25% being rehospitalized within one month.SGLT inhibitorsheart failure with preserved ejection fraction (HFpEF)SGLT2HFpEF
“Based on outcomes observed in the SOLOIheart failure initiating treatment with INPEFA prior to or upon hospital disHeart failuree potential to reduce the burden of readmissions on patients, caregivers, providers, and health systems,” said Craig Granowitz, M.D., Ph.D., Lexicon’s seheart failuresident and chief medical oheart failure today’s FDA approval, INPEFA is now a valuable option for physicians to consider when treating patients transitioning out of the hospital and working to break the cycle of repeated hospitalizations.”
Lexiconnce Call and Webcast Informationheart failure
Lexicon management will hold a live conference call and webcast Tuesday, May 30, 2023, at 8:00 am ET / 7:00 am CT. The dial-in number for the conference call is 888-317-6003 and the conference ID for all callers is 0516154. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/events. An archived version of the webcast will be available on the website for 14 days.
DiscovINPEFAsinsotagliflozinnique approach to gene science, INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose reabsorption by the kidney and SGLT1 is responsible for glucose absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.
INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:
INPEFAfailure orheart failureheart failure
heart failurees mellitus, chronic kidney disease, and other cardiovascular risk factors
Dosing: Assess renal function and volume status and, if necessary, correct volume depletion prior to initiation of INPEFA. INPEFA dosing for patients with decompensated heart failure may begin when patients are hemodynamically stable, including when hospitalized or immediately upon discharge.
Ketoacidosis: INPEFINPEFAeases the risk of ketoacidosis in pathypersensitivity1 diINPEFA mellitus (T1DM). Type 2 diabetes Mellitus (T2DM) and pancreatic disorders are also risk factors. The risk of ketoacidosis may be greater with higher doses. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes using sodium glucose transporter 2 (SGLT2) inhibitors. Before initiating INPEFA, assess risk factors for ketoacidosis. Consider ketone monitoring in patients with T1DM and consider ketone monitoring in others at risk for ketoacidosis and educate patients on the signs/symptoms of ketoacidosis. Patients receiving INPEFA may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis. INPEFA is not indicated for glycemic control.
KetoacidosisntINPEFApresent with signs and ketoacidosismetabolic acidosistype 1 diabetes mellitus (T1DM) bType 2 diabetes Mellitus (T2DM)d, dipancreatic disordersaluate, and treat promptly. Monitor ketoacidosis resolution of ketoacidosis before restarting INPEFA.ketoacidosistype 2 diabetessodium glucose transporter 2 (SGLT2) inhibitorsINPEFAketoacidosisT1DMketoacidosisketoacidosisINPEFAketoacidosisINPEFA
Volume Depletion: INPEFA can cause intravascular volumemetabolic acidosisay sketoacidosisifest as symptomatic hypotension or acute transient changes in INPEFAnine. There have been post-marketing reports of acute kidney injuryketoacidosisring hospitalizatioINPEFAdialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors. Patients with impaired renal function (eGFR Urosepsis and Pyelonephritis: Treatment with SGLT2 inhibitors, including INPEFA, increases the risk for urinary tract infections. Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been reported. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly.
Hypoglycemia with INPEFAitant Use with Insulin and Insulin Secretagogues: Insulin and insulin secretagogues arhypotensioncause hypoglycemia. INPEFA may increase the risk of hypoglycemia when combined with iacute kidney injuryn secretagogue. Therefore, a lower dose of insulin or insulin setype 2 diabetes mellitused to minimSGLT2he risk of hypoglycemia when used with INPEFA.UrosepsisPyelonephritisSGLT2INPEFAurinary tract infectionsurinary tract infectionsurosepsispyelonephritisurinary tract infections
HypoglycemiaFasciitis of the Perineum (Fournier’s GInsulin SecretagoguesFournier’s Ganinsulin secretagoguesious and life-threathypoglycemiaizINPEFAfection requiring urgent shypoglycemiarvention, have been identified in insulin secretagogueillance in patients with diabetes mellitinsulin secretagoguenhibitors. Assess patients who present wihypoglycemiaderness, erythemINPEFAswelling in the genital or perineal area, along with fever or malaise. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue INPEFA, closely monitor patient signs and symptoms, and provide appropriate alternative therapy for heart failure.
Necrotizing Fasciitistions: INPEFA increases the risk of genital mycotic infecti’s Gangrener and treat as appropriate.necrotizing infectiondiabetes mellitusSGLT2painerythemaswellingfeverINPEFAheart failure
Genital Mycotic Infections,5INPEFAroglucitol (1,5-AG) Assgenital mycotic infections for patients taking SGLT2 inhibitors. Use alternative testing methods to monitor glucose levels.
Common Adverse Reactions: the most commonly reported adverse reactions (incidence ≥ 5%) were urinary traSGLT2fection, volume depletion, diarrhea, and hypoglycemia.
Drug Interactions:urinary tract infectionvolume depletiondiarrheahypoglycemia
Digoxin: Monitor patients appropriately as there is an increase in the exposure of digoxin when coadministered with INPEFA 400 mg.
Lithium: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithirifampicinrations. Monitor serum lithsotagliflozintion more frequently during INPEFA initiatisotagliflozinosage changes.
Pregnancy and Lactation: INPEFA is not recommended during the second and third trimesters of pregnancy, nor while breastfeeding.
Geriatric Use: No INPEFA INPEFA change is recommended based on age. No overall differences in efficacy were detected between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for volume depletion adverse reactions, including hypotension.
Renal Impairment: INPEFA was evaluated in patients with chronic kidney disease (eGFR 25 to 60 mL/min/1.73 m²) and in patients with heart failure with eGFR Hepatic Impairment: INPEFA is not recommended in patients with moderate or severe hepatic impairment.hypotension
About Heart Failure
About Heart Failuremericans suffer from heart failure, a progressive, debilitating condition that is becoming more prevalent. Heart failure is the leading cause of hospitalizations for individuals aged 65 and older, triggering approximately 1.3 million hospitalizations a year.
About the SOLOIST-WHF Studyheart failureHeart failure
SOLOIST-WHF was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.
SOLOIST-WHF achieved its primary endpoint, with overall tolerability similar to placebo. Results were presented at the Late-Breaking Scsotagliflozin of the American Heart Association (AHA) Scientific Sessions 2020 and type 2 diabetespublished in The New England Journal of Medicine (heart failurerticle titled: “Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure.”heart failureheart failuresotagliflozin
About the SCORED StudySotagliflozinDiabetesHeart Failure
SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 ml to 60 ml per minute per 1.73 m2 of body-surface area, and risks for cardiovascular disease. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo. Key secondary endpoints included total number of events of deaths from cardiovascular causes, non-fatal myocardial infarction, and non-fatal stroke.
SCORED achieved its primary endpoint, with overall tolerability similar to placebo. Results were presented at the Late-Breaking Scsotagliflozin of the American Heart Association (AHA) Scientific Sessions 2020 and stype 2 diabetesubchronic kidney diseaseand Journal of Medicine (NEJM) in an article titled: “Sotagliflozin in Patients with Diacardiovascular diseaseey Disease.”heart failureheart failuresotagliflozinnon-fatal myocardial infarctionnon-fatal stroke
About Lexicon PharmaceuticalsSotagliflozinDiabetesChronic Kidney Disease
LexicoLexicon Pharmaceuticalsl company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat diseases safely and effectively. Lexicon has previously advanced one of these medicines to market and has a pipeline of promising drug candidates in heart failure, neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.
This press release contains “forward-looking statements,” including statements relating to the therapeutic and commercial potential, research and clinical development and regulatory status of INPEFA™ (sotagliflozin). In addition, this press release also contains forward looking statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize INPEFA in heart failure on the timeline and/or at the prices currently contemplated or at all, conduct preclinical and clinical development and obtain necessary regulatory approvals of INPEFA (in other indications), LX9211 and its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2022, quarterly report on Form 10-Q for the quarter ended March 31, 2023 and other subsequent disclosure documents filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
Carrie Siragusa
Lexicon Pharmaceuticals, Inc.
For Media Inquiries:
Alina Cocuzza
Lexicon Pharmaceuticals, Inc.
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