Lexicon Announces FDA Acceptance of New Drug Application for Sotagliflozin to Treat Heart Failure
July 27 2022 - 7:59AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced
that the U.S. Food and Drug Administration (FDA) has accepted for
review and filed its New Drug Application (NDA) for sotagliflozin,
an investigational dual SGLT1 and SGLT2 inhibitor, for the
treatment of heart failure. The FDA assigned a standard review for
the NDA filing with a Prescription Drug User Fee Act (PDUFA) target
action date in May 2023.
“This is an important step in potentially
bringing sotagliflozin to market as a new treatment for heart
failure,” said Lonnel Coats, Lexicon’s chief executive officer.
“Informed by our regulatory discussions, we are seeking a broad
heart failure label in the NDA encompassing heart failure patients
with and without diabetes, and believe that the results of
SOLOIST-WHF in patients admitted for recent worsening heart failure
will be an important element distinguishing our proposed label. We
look forward to engaging with the FDA during the review process to
bring this potential new treatment to market by the middle of next
year.”
The NDA is supported by the results from the
Phase 3 SOLOIST-WHF clinical study in patients with type 2 diabetes
who had recently been hospitalized for worsening heart failure and
the Phase 3 SCORED clinical study in patients with type 2 diabetes,
chronic kidney disease and risks for cardiovascular disease. In the
NDA, Lexicon is seeking that sotagliflozin be indicated to:
- Reduce the risk of cardiovascular
death, hospitalization for heart failure, and urgent heart failure
visit in adults with heart failure, including those with acute or
worsening heart failure.
- Reduce the risk of cardiovascular
death, hospitalization for heart failure, urgent heart failure
visit, nonfatal myocardial infarction, and nonfatal stroke in
adults with type 2 diabetes mellitus, chronic kidney disease, and
other cardiovascular risk factors, including a history of heart
failure.
About the SOLOIST-WHF and SCORED
Studies
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 people 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 people treated with
sotagliflozin compared with placebo.
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 people with type 2 diabetes, chronic
kidney disease with eGFR of 25 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 people treated with
sotagliflozin compared with placebo.
Both SOLOIST-WHF and SCORED achieved their
respective primary endpoints, with overall tolerability similar to
placebo across both trials. Results from both studies 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 two
separate articles titled: “Sotagliflozin in Patients with Diabetes
and Recent Worsening Heart Failure” and “Sotagliflozin in Patients
with Diabetes and Chronic Kidney Disease.”
About Sotagliflozin Discovered
using Lexicon’s unique approach to gene science, sotagliflozin is
an 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,” within the meaning of the federal securities laws,
including, but not limited to, statements relating to the timing,
clinical development of, regulatory filings and proposed label for,
and potential therapeutic and commercial potential of
sotagliflozin. 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,
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, 2021, quarterly report on Form
10-Q for the quarter ended March 31, 2022 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 Inquiries:
Mike KellyLexicon
Pharmaceuticalsmkelly@lexpharma.com
Lexicon Pharmaceuticals (NASDAQ:LXRX)
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