Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced
that the peer-reviewed Journal of the American College of
Cardiology: Heart Failure has published a research paper concluding
that INPEFA® (sotagliflozin) is cost-effective for people with
diabetes and recent worsening heart failure using commonly accepted
willingness-to-pay thresholds.
“Our research team believes that this study is an important
contribution to the economic evaluation of sotagliflozin, a novel
SGLT inhibitor, from the perspective of the U.S. healthcare system.
Our results demonstrated that in people with diabetes and recent
worsening heart failure, sotagliflozin is cost-effective at
commonly accepted willingness-to-pay thresholds,” said William S.
Weintraub, MD, MACC, FAHA, FESC, director of Population Health
Research at MedStar Health Research Institute, and the lead author
of the research paper.
The analysis was conducted from a U.S. healthcare sector
perspective, in accordance with Consolidated Health Economic
Evaluation Reporting Standards. Results from this study showed that
lifetime quality-adjusted life-years (QALYs) were 4.43 and 4.04 in
the INPEFA and placebo groups, respectively.
In another study, “Cost-effectiveness of sotagliflozin
for the treatment of patients with diabetes and recent worsening
heart failure,” recently published in the Journal of
Comparative Effectiveness Research, the research team used
published real-world data to derive baseline event frequencies and
SOLOIST-WHF study data to estimate the efficacy of INPEFA.
According to the research results, the use of INPEFA led to a net
gain in QALYs of 0.425 for INPEFA versus standard of care. The
investigators concluded that INPEFA is a cost-effective addition to
standard of care for patients hospitalized with heart failure and
comorbid diabetes.
“The data published in these two peer-reviewed journals
reinforce our position that in addition to providing meaningful
clinical benefits to heart failure patients, INPEFA provides
significant financial value for payors and the U.S. healthcare
system,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice
president and chief medical officer.
The Journal of the American College of Cardiology: Heart Failure
manuscript can be accessed here.
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of
pioneering medicines that transform patients’ lives. Through the
Genome5000™ program, Lexicon’s unique genomics target discovery
platform, 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 disease safely and effectively. Lexicon has commercially
launched one of these medicines, INPEFA® (sotagliflozin) in the
United States, and has a pipeline of other promising drug
candidates in discovery and clinical and preclinical development in
neuropathic pain, diabetes and metabolism and other
indications. For additional information, please
visit www.lexpharma.com.
About
INPEFA® (sotagliflozin)
Discovered using Lexicon’s unique 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 and sodium reabsorption by the kidney and SGLT1 is
responsible for glucose and sodium 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.
INDICATION
INPEFA is indicated to reduce the risk of cardiovascular death,
hospitalization for heart failure, and urgent heart failure visit
in adults with:
- heart failure or
- type 2 diabetes mellitus, chronic kidney disease, and other
cardiovascular risk factors
IMPORTANT SAFETY INFORMATION
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.
Contraindications: INPEFA is contraindicated in
patients with hypersensitivity to INPEFA or any of its
components.
Ketoacidosis: INPEFA increases the risk of
ketoacidosis in patients with type 1 diabetes 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.
Assess patients who present with signs and symptoms of metabolic
acidosis or ketoacidosis, regardless of blood glucose level. If
suspected, discontinue INPEFA, evaluate, and treat promptly.
Monitor patients for resolution of ketoacidosis before restarting
INPEFA.
Volume Depletion: INPEFA can cause
intravascular volume depletion which may sometimes manifest as
symptomatic hypotension or acute transient changes in creatinine.
There have been post-marketing reports of acute kidney injury, some
requiring hospitalization and dialysis, in patients with type 2
diabetes mellitus receiving SGLT2 inhibitors. Patients with
impaired renal function (eGFR < 60 mL/min/1.73 m2), elderly
patients, or patients on loop diuretics may be at increased risk
for volume depletion or hypotension. Before initiating INPEFA in
patients with one or more of these characteristics, assess volume
status and renal function, and monitor for signs and symptoms of
hypotension during therapy.
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 Concomitant Use with Insulin and
Insulin Secretagogues: Insulin and insulin secretagogues
are known to cause hypoglycemia. INPEFA may increase the risk of
hypoglycemia when combined with insulin or an insulin
secretagogue. Therefore, a lower dose of insulin or insulin
secretagogue may be required to minimize the risk of hypoglycemia
when used with INPEFA.
Necrotizing Fasciitis of the Perineum (Fournier’s
Gangrene): Reports of Fournier’s Gangrene, a rare but
serious and life-threatening necrotizing infection requiring urgent
surgical intervention, have been identified in post-marketing
surveillance in patients with diabetes mellitus receiving SGLT2
inhibitors. Assess patients who present with pain, tenderness,
erythema, or swelling 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.
Genital Mycotic Infections: INPEFA increases
the risk of genital mycotic infections. Monitor and treat as
appropriate.
Urinary Glucose Test and 1,5-anhydroglucitol (1,5-AG)
Assay: these are not reliable 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 tract
infection, volume depletion, diarrhea, and hypoglycemia.
Drug Interactions:
- Digoxin: Monitor patients appropriately as
there is an increase in the exposure of digoxin when coadministered
with INPEFA 400 mg.
- Uridine 5'-diphospho-glucuronosyltransferase (UGT)
Inducer: The coadministration of rifampicin, an inducer of
UGTs, with sotagliflozin resulted in a decrease in the exposure of
sotagliflozin.
- Lithium: Concomitant use of an SGLT2 inhibitor
with lithium may decrease serum lithium concentrations. Monitor
serum lithium concentration more frequently during INPEFA
initiation and with dosage changes.
Use in Specific Populations:
- Pregnancy and Lactation: INPEFA is not
recommended during the second and third trimesters of pregnancy,
nor while breastfeeding.
- Geriatric Use: No INPEFA dosage 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 < 60 mL/min/1.73
m2. The safety profile of INPEFA across eGFR subgroups in these
studies was consistent with the known safety profile. There was an
increase in volume-related adverse events (e.g., hypotension,
dizziness) in patients with eGFR
< 30 mL/min/1.73m2 relative to the overall safety
population. Efficacy and safety studies with INPEFA did not enroll
patients with an eGFR less than 25 mL/min/1.73 m2 or on dialysis.
After starting therapy in the studies, patients were discontinued
if eGFR fell below 15 mL/min/1.73 m2 or were initiated on chronic
dialysis.
- Hepatic Impairment: INPEFA is not recommended
in patients with moderate or severe hepatic impairment.
Click here for full Prescribing Information.
https://www.lexpharma.com/inpefa-US-PI.pdf
Safe Harbor Statement
This press release contains “forward-looking
statements,” including statements relating to Lexicon’s financial
position and long-term outlook on its business, growth and future
operating results, discovery, development and commercialization 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, conduct preclinical and clinical development and
obtain necessary regulatory approvals of sotagliflozin (in other
indications), LX9211, LX9851 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 products and 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, 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.
For Investor
Inquiries:
Lisa DeFrancescoLexicon Pharmaceuticals,
Inc.lexinvest@lexpharma.com
For Media Inquiries:
Alina Cocuzza Lexicon Pharmaceuticals,
Inc. acocuzza@lexpharma.com
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