GENFIT: Ipsen’s Iqirvo® (Elafibranor) Receives EU Approval as a First-in-Class Treatment for Primary Biliary Cholangitis following U.S. FDA Accelerated Approval
September 23 2024 - 1:30AM
UK Regulatory
GENFIT: Ipsen’s Iqirvo® (Elafibranor) Receives EU Approval as a
First-in-Class Treatment for Primary Biliary Cholangitis following
U.S. FDA Accelerated Approval
Lille (France), Cambridge (Massachusetts,
United States), Zurich (Switzerland), September 23, 2024 -
GENFIT (Nasdaq and Euronext: GNFT), a late-stage
biopharmaceutical company dedicated to improving the lives of
patients with rare and life-threatening liver diseases, today
announced that the European Commission has conditionally approved
Iqirvo®1 (elafibranor) 80mg tablets for the treatment of
Primary Biliary Cholangitis (PBC) in combination with
ursodeoxycholic acid (UDCA) in adults with an inadequate response
to UDCA or as a monotherapy in patients unable to tolerate UDCA.
This follows the positive opinion issued by the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) on July 26, 2024 and the U.S. FDA Accelerated Approval
on June, 10, 2024 .
Pascal Prigent, CEO of GENFIT,
commented: “The approval of Iqirvo in the EU is another
landmark moment for GENFIT. Iqirvo’s EU approval provides further
validation of our scientific and clinical capabilities,
demonstrating how we are capable of taking a drug candidate all the
way from discovery to the end of a Phase 3, with Iqirvo now
becoming a new treatment option for patients. The expected €26.5
million milestone payment upon Iqirvo’s pricing and reimbursement
approval in three European countries, will enable us to drive
forward with our robust pipeline for other severe liver diseases
with high unmet need, including Acute On-Chronic Liver
Failure.”
Elafibranor, a 'first-in-class' molecule
marketed and commercialized in the United States by Ipsen under the
trademark Iqirvo since June 2024, was developed by GENFIT, from
initial discovery to the conclusion of a 52-week Phase 3 clinical
study. Ipsen licensed the exclusive worldwide rights (except China,
Hong Kong, Taiwan and Macau) to elafibranor from GENFIT in
2021.
Further details can be found here.
EU SUMMARY OF PRODUCT
CHARACTERISTICS
Important safety information and recommendations
for the use of Iqirvo are detailed in the Summary of Product
Characteristics (SmPC), published in the European public assessment
report (EPAR) and available in all official EU languages. The full
SmPC can be found at: Iqirvo, INN-elafibranor (europa.eu).
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
committed to improving the lives of patients with rare,
life-threatening liver diseases whose medical needs remain largely
unmet. GENFIT is a pioneer in liver disease research and
development with a rich history and a solid scientific heritage
spanning more than two decades. Today, GENFIT has built up a
diversified and rapidly expanding R&D portfolio of programs at
various stages of development. The Company focuses on
Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes
five assets under development: VS-01, NTZ, SRT-015, CLM-022 and
VS-02-HE, based on complementary mechanisms of action using
different routes of administration. Other assets target other
serious diseases, such as cholangiocarcinoma (CCA), urea cycle
disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the
development of high-potential molecules from early to advanced
stages, including pre-commercialization, was demonstrated in the
FDA’s accelerated approval of Iqirvo® (elafibranor2) for
Primary Biliary Cholangitis (PBC). Beyond therapies, GENFIT also
has a diagnostic franchise including NIS2+® in Metabolic
dysfunction-associated steatohepatitis (MASH, formerly known as
NASH for non-alcoholic steatohepatitis) and TS-01 focusing on blood
ammonia levels. GENFIT is headquartered in Lille, France and has
offices in Paris (France), Zurich (Switzerland) and Cambridge, MA
(USA). The Company is listed on the Nasdaq Global Select Market and
on the Euronext regulated market in Paris, Compartment B (Nasdaq
and Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest
shareholders, acquiring an 8% stake in the Company's capital.
www.genfit.com
FORWARD LOOKING STATEMENTS
This press release contains certain
forward-looking statements, including those within the meaning of
the Private Securities Litigation Reform Act of 1995 with respect
to GENFIT. The use of certain words, such as "believe",
"potential", "expect", “target”, “may”, “will”, "should", "could",
"if" and similar expressions, is intended to identify
forward-looking statements. Although the Company believes its
expectations are based on the current expectations and reasonable
assumptions of the Company’s management, these forward-looking
statements are subject to numerous known and unknown risks and
uncertainties, which could cause actual results to differ
materially from those expressed in, or implied or projected by, the
forward-looking statements. These risks and uncertainties include,
among others, the uncertainties inherent in research and
development, including in relation to safety of drug candidates,
cost of, progression of, and results from, our ongoing and planned
clinical trials, review and approvals by regulatory authorities in
the United States, Europe and worldwide, of our drug and diagnostic
candidates, potential commercial success of elafibranor if
approved, exchange rate fluctuations, and our continued ability to
raise capital to fund our development, as well as those risks and
uncertainties discussed or identified in the Company’s public
filings with the AMF, including those listed in Chapter 2 "Risk
Factors and Internal Control" of the Company's 2023 Universal
Registration Document filed on April 5, 2024 (no. D.24-0246) with
the Autorité des marchés financiers ("AMF"), which is
available on GENFIT's website (www.genfit.fr) and the AMF's website
(www.amf.org), and those discussed in the public documents and
reports filed with the U.S. Securities and Exchange Commission
("SEC"), including the Company’s 2023 Annual Report on Form 20-F
filed with the SEC on April 5, 2024 and subsequent filings and
reports filed with the AMF or SEC or otherwise made public, by the
Company. In addition, even if the results, performance, financial
position and liquidity of the Company and the development of the
industry in which it operates are consistent with such
forward-looking statements, they may not be predictive of results
or developments in future periods. These forward-looking statements
speak only as of the date of publication of this document. Other
than as required by applicable law, the Company does not undertake
any obligation to update or revise any forward-looking information
or statements, whether as a result of new information, future
events or otherwise.
CONTACT
GENFIT | Investors
Tel: +33 3 2016 4000 | investors@genfit.com
GENFIT | Media
Stephanie Boyer – Press relations | Tel: +333
2016 4000 | stephanie.boyer@genfit.com
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos -
FRANCE | +333 2016 4000 | www.genfit.com
1 Iqirvo is a registered trademark by GENFIT SA
2 Elafibranor is marketed and commercialized in the U.S by Ipsen
under the trademark Iqirvo
- GENFIT: Ipsen’s Iqirvo® (Elafibranor) Receives EU Approval as a
First-in-Class Treatment for Primary Biliary Cholangitis following
U.S. FDA Accelerated Approval
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