GENFIT: Ipsen’s Iqirvo® (Elafibranor) Receives EU Approval as a First-in-Class Treatment for Primary Biliary Cholangitis following U.S. FDA Accelerated Approval
23 9월 2024 - 2:30PM
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 SA2 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
Genfit (EU:GNFT)
과거 데이터 주식 차트
부터 10월(10) 2024 으로 11월(11) 2024
Genfit (EU:GNFT)
과거 데이터 주식 차트
부터 11월(11) 2023 으로 11월(11) 2024
