New Analysis Finds Sotagliflozin to Be a Cost-Effective Treatment at Commonly Accepted Willingness-to-Pay Threshold in Patients with Worsening Heart Failure
May 10 2023 - 4:30PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that
results of a new investigator-initiated economic analysis, based on
results from the SOLOIST-WHF Phase 3 outcomes study of its
investigational medicine sotagliflozin, were presented on May 9 at
the International Society for Pharmacoeconomics and Outcomes
Research (ISPOR) annual meeting in Boston, Massachusetts.
The analysis was led by the MedStar Health
Research Institute in Washington, D.C. and was conducted from a
U.S. healthcare sector perspective, in accordance with Consolidated
Health Economic Evaluation Reporting Standards. The analysis was
based on nine-month median follow-up data from the 1,222 patients
enrolled in the Phase 3 SOLOIST-WHF trial and designed to
extrapolate costs, life expectancy, and quality-adjusted life
expectancy to estimate sotagliflozin’s cost-effectiveness. The
researchers determined that sotagliflozin is a clinically and
economically attractive medication and is cost-effective at
commonly accepted willingness-to-pay thresholds in patients with
diabetes and worsening heart failure.
Heart failure is the leading cause of
hospitalization for Americans over the age of 65. Patients with
heart failure are at highest risk of having a repeat heart failure
event in the first 30 days post-discharge, with 7% dying and 25%
being rehospitalized within one month.
“With the prevalence of heart failure rising at
an ever-increasing rate and hospitalizations driving a significant
majority of healthcare costs relating to heart failure, it is clear
that we need to do more,” said Craig Granowitz, M.D., Ph.D.,
Lexicon’s senior vice president and chief medical officer. “We are
closer than ever to potentially providing an additional treatment
option for heart failure patients transitioning out of the hospital
and helping to reduce the financial and physical burdens of
rehospitalizations.”
Results from SOLOIST-WHF showed that
sotagliflozin significantly reduced hospitalizations for heart
failure, urgent visits for heart failure, and the risk of
cardiovascular deaths by 33% compared to placebo. Further post-hoc
analyses concluded that initiating treatment with sotagliflozin
prior to hospital discharge reduced the composite of urgent care
for heart failure or cardiovascular death within 27 days and that
sotagliflozin reduced the risk of cardiovascular death and heart
failure hospitalizations by approximately 50% at 30 and 90 days
after discharge, compared to placebo. These findings were generally
consistent across the range of left ventricular ejection fraction,
or LVEF.
Lexicon’s NDA for sotagliflozin for the
treatment of heart failure is on track for its May 27, 2023 PDUFA
action date.
About Heart Failure
About 6.7 million Americans suffer from heart
failure, a progressive, debilitating condition that is becoming
more prevalent. It is the leading cause of hospitalizations for
people aged 65 and older, triggering approximately 1.3 million
hospitalizations a year. Annual costs from heart failure are
expected to increase to nearly $70 billion by 2030, with 80% of
those costs due to hospitalizations.
About the SOLOIST-WHF Study
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 Science Session of the American Heart Association
(AHA) Scientific Sessions 2020 and simultaneously published in The
New England Journal of Medicine (NEJM) in an article titled:
“Sotagliflozin in Patients with Diabetes and Recent Worsening Heart
Failure,” which may be accessed at www.nejm.org.
About Sotagliflozin
Discovered using Lexicon’s unique approach to
gene science, sotagliflozin is an investigational oral dual
inhibitor of two proteins responsible for glucose regulation known
as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2).
SGLT1 is responsible for glucose absorption in the gastrointestinal
tract, and SGLT2 is responsible for glucose reabsorption by the
kidney. Sotagliflozin has been studied in multiple patient
populations encompassing heart failure, type 1 and type 2 diabetes,
and chronic kidney disease in fourteen Phase 3 clinical studies
involving approximately 20,000 patients.
About Lexicon
Pharmaceuticals
Lexicon is a biopharmaceutical 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 safely and effectively treat disease. Lexicon advanced
one of these medicines to market and has a pipeline of promising
drug candidates in discovery and clinical and preclinical
development in heart failure, neuropathic pain, diabetes and
metabolism and other indications. For additional information,
please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking
statements,” including statements relating to the research and
clinical development of, regulatory filings for, and potential
therapeutic and commercial potential of 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 conduct preclinical and clinical development and
obtain necessary regulatory approvals of sotagliflozin, LX9211 and
its other potential drug candidates on its anticipated timelines,
successfully commercialize any products for which it obtains
regulatory approval, 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, as 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:
Carrie SiragusaLexicon Pharmaceuticals,
Inc.csiragusa@lexpharma.com
For Media Inquiries:
Alina CocuzzaLexicon Pharmaceuticals,
Inc.acocuzza@lexpharma.com
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