- Ipsen’s Iqirvo®
(elafibranor) 80 mg tablets receives U.S. FDA accelerated
approval as a first-in-class treatment for Primary Biliary
Cholangitis (PBC)
- First-ever drug developed in-house by GENFIT to achieve
U.S. FDA’s approval
- GENFIT is eligible to receive a €48.7 million milestone
payment from Ipsen upon the first commercial sale of Iqirvo in the
U.S., as well as tiered double-digit royalties of up to
20%
Lille (France), Cambridge
(Massachusetts, United States), Zurich (Switzerland), June 10,
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 the achievement of a historic
corporate milestone: the U.S. Food and Drug Administration (FDA)
accelerated approval of Iqirvo1 (elafibranor)2 80 mg tablets – as
unveiled today by Ipsen (Euronext: IPN; ADR: IPSEY) – as a
first-in-class treatment for PBC in combination with
ursodeoxycholic acid (UDCA) in adults with an inadequate response
to UDCA, or as monotherapy in patients unable to tolerate UDCA.
Elafibranor will be marketed and commercialized
by Ipsen under the trademark Iqirvo and may be prescribed
immediately in the U.S. for eligible patients.
This indication is approved under accelerated
approval based on reduction of alkaline phosphatase (ALP).
Improvement in survival or prevention of liver decompensation
events have not been demonstrated. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in confirmatory trial(s). Iqirvo is not
recommended for people who have or who develop decompensated
cirrhosis (e.g., ascites, variceal bleeding, hepatic
encephalopathy).
Pascal Prigent, CEO of GENFIT,
commented: “This approval is a source of pride for all GENFIT
employees. We took elafibranor (Iqirvo) all the way from drug
discovery to the end of Phase 3 and now, thanks to our partnership
with Ipsen, it will be made available to healthcare providers in
the US and ultimately provide patients with a valuable therapeutic
alternative. The upcoming launch is both a major achievement and
the beginning of a new chapter, as we expect that the revenues
derived from the commercialization of elafibranor will now finance
the development of a new and exciting portfolio of programs focused
on ACLF.”
In 2024, as previously communicated, GENFIT
expects to receive total milestone payments from Ipsen of
approximately €89 million, including €48.7 million upon the first
commercial sale of Iqirvo in the U.S., and a €13.3 million
milestone payment which was invoiced in December 2023, and received
in February 2024.
These revenues present GENFIT with new financial
opportunities and will help to finance our strategic pivot towards
Acute on-Chronic Liver Failure (ACLF) and other liver diseases.
ENDS
IMPORTANT SAFETY
INFORMATION
Myalgia, Myopathy, and Rhabdomyolysis:
Rhabdomyolysis resulting in acute kidney injury occurred in one
IQIRVO-treated patient who had cirrhosis at baseline and was also
taking a stable dose of an HMG-CoA reductase inhibitor (statin).
Myalgia or myopathy, with or without CPK elevations, occurred in
patients treated with IQIRVO alone or treated concomitantly with a
stable dose of an HMG-CoA reductase inhibitor. Assess for myalgia
and myopathy prior to IQIRVO initiation. Consider periodic
assessment (clinical exam, CPK measurement) during treatment with
IQIRVO, especially in those who have signs and symptoms of new
onset or worsening of muscle pain or myopathy. Interrupt IQIRVO
treatment if there is new onset or worsening of muscle pain, or
myopathy, or rhabdomyolysis.
Fractures: Fractures occurred in 7% of
IQIRVO-treated patients compared to 0% in placebo-treated
patients. Consider the risk of fracture in the care of patients
treated with IQIRVO and monitor bone health according to current
standards of care.
Adverse Effects on Fetal and Newborn
Development: IQIRVO may cause fetal harm when administered
during pregnancy. For females of reproductive potential, verify
that the patient is not pregnant prior to initiation of therapy.
Advise females of reproductive potential to use effective
non-hormonal contraceptives or add a barrier method when using
systemic hormonal contraceptives during treatment with IQIRVO and
for 3 weeks following the last dose of IQIRVO.
Drug-Induced Liver Injury: Suspected
drug-induced liver injury occurred in one patient who took IQIRVO
80 mg once daily and two patients who took IQIRVO at 1.5-times the
recommended dosage, of which one presented with autoimmune-like
hepatitis. The median time to onset of elevation in liver tests was
85 days. Obtain baseline clinical, laboratory and imaging
assessments at treatment initiation with IQIRVO and monitor
thereafter according to routine patient management. Interrupt
IQIRVO treatment if liver tests (ALT, AST, total bilirubin [TB],
and/or alkaline phosphatase [ALP]) worsen, or the patient develops
signs and symptoms consistent with clinical hepatitis (e.g.,
jaundice, right upper quadrant pain, eosinophilia). Consider
permanent discontinuation if liver tests worsen after restarting
IQIRVO.
Hypersensitivity Reactions: Hypersensitivity
reactions have occurred in a clinical trial with IQIRVO at
1.5-times the recommended dosage. Three patients (0.2%) had rash or
unspecified allergic reaction that occurred 2 to 30 days after
IQIRVO initiation. Hypersensitivity reactions resolved after
discontinuation of IQIRVO and treatment with steroids and/or
antihistamines. If a severe hypersensitivity reaction occurs,
permanently discontinue IQIRVO. If a mild or moderate
hypersensitivity reaction occurs, interrupt IQIRVO and treat
promptly. Monitor the patient until signs and symptoms resolve. If
a hypersensitivity reaction recurs after IQIRVO rechallenge, then
permanently discontinue IQIRVO.
Biliary Obstruction: Avoid use of IQIRVO in
patients with complete biliary obstruction. If biliary obstruction
is suspected, interrupt IQIRVO and treat as clinically
indicated.
Drug-Drug InteractionsIQIRVO may reduce the
systemic exposure of progestin and ethinyl estradiol (CYP3A4
substrates), which may lead to contraceptive failure and/or an
increase in breakthrough bleeding. Switch to effective non-hormonal
contraceptives or add a barrier method when using hormonal
contraceptives during treatment with IQIRVO and for at least 3
weeks after last dose.
CPK elevation and/or myalgia occurred in patients on IQIRVO
monotherapy. Co-administration of IQIRVO and HMG-CoA reductase
inhibitors can increase the risk of myopathy. Monitor for signs and
symptoms of muscle injury. Consider periodic assessment (clinical
exam, CPK) during treatment. Interrupt IQIRVO treatment if there is
new onset or worsening of muscle pain or myopathy.
Co-administration of IQIRVO with rifampin, an inducer of
metabolizing enzymes, may reduce the systemic exposure of
elafibranor resulting in delayed or suboptimal biochemical
response. Monitor the biochemical response (e.g., ALP and
bilirubin) when patients initiate rifampin during treatment with
IQIRVO.
Bile acid sequestrants may interfere with IQIRVO absorption and
systemic exposure, which may reduce efficacy. Administer IQIRVO at
least 4 hours before or after a bile acid sequestrant, or at as
great an interval as possible.
Use in Special
PopulationsPregnancy: Based on data from
animal reproduction studies, IQIRVO may cause fetal harm when
administered during pregnancy. There are insufficient data from
human pregnancies exposed to IQIRVO to allow an assessment of a
drug-associated risk of major birth defects, miscarriage, or other
adverse maternal or fetal outcomes. Report pregnancies to Ipsen
Pharmaceuticals, Inc. Adverse Event reporting line at
1-855-463-5127 or https://www.ipsen.com/contact-us/.
Lactation: There are no data available on the
presence of IQIRVO or its metabolites in human milk, or on effects
of the drug on the breastfed infant or the effects on milk
production. IQIRVO is not recommended during breastfeeding and for
at least 3 weeks following last dose of IQIRVO because the risk to
breastfed child cannot be excluded.
Females and Males of Reproductive Potential:
IQIRVO may cause fetal harm when administered to pregnant women.
Verify the pregnancy status of females of reproductive potential
prior to initiating IQIRVO. Advise females of reproductive
potential to use effective contraception during treatment with
IQIRVO and for 3 weeks after the final dose.
The most common adverse events occurring in ≥10% of patients
were weight gain (23%), abdominal pain (11%), nausea (11%),
vomiting (11%), and diarrhea (11%).
You are encouraged to report side effects to FDA at
(800) FDA-1088 or
www.fda.gov/medwatch. You may also report
side effects to Ipsen Pharmaceuticals at
1-855-463-5127.
Please see full
Prescribing Information for
IQIRVO.
ABOUT IQIRVO
Iqirvo (pronounced EYE-KER-VO) is an oral, once-daily,
peroxisome proliferator-activated receptor (PPAR) agonist indicated
for the treatment of primary biliary cholangitis (PBC) in
combination with ursodeoxycholic acid (UDCA) in adults who have an
inadequate response to UDCA, or as monotherapy in patients unable
to tolerate UDCA. While the mechanism is not well understood,
pharmacological activity that is potentially relevant to Iqirvo
therapeutic effects includes inhibition of bile acid synthesis
through activation of PPAR-alpha and PPAR-delta. In 2019, Iqirvo
was granted Breakthrough Therapy Designation by the U.S Food and
Drug Administration (FDA) in adults with PBC who have an inadequate
response to ursodeoxycholic acid (UDCA) the existing first-line
therapy for PBC. Iqirvo has not received approval by regulatory
authorities outside of the U.S. Iqirvo is currently under
regulatory review with the European Medicines Agency (EMA) and the
UK Medicines and Healthcare products Regulatory Agency (MHRA).
Iqirvo was discovered and developed by GENFIT and Ipsen licensed
the exclusive worldwide rights (except China, Hong Kong, Taiwan and
Macau) to elafibranor from GENFIT in 2021.
Iqirvo has been granted approval under the FDA accelerated
approval program, which allows for approval of medicines that treat
serious conditions and fill an unmet medical need based on a
surrogate endpoint. Under the program, Ipsen is required to conduct
a trial to confirm anticipated clinical benefit. The confirmatory
trial for Iqirvo, ELFIDENCE, is ongoing.
Iqirvo is a 80 mg tablet administered orally once daily. To
ensure access to Iqirvo for eligible individuals in the U.S., the
IPSEN CARES® patient support program is available as a resource to
people living with PBC and their caregivers to provide educational
support and address coverage, access and reimbursement questions
(1-866-435-5677).
ABOUT THE PHASE III ELATIVE®
TRIAL
ELATIVE1 is a multi-center, randomized double-blind,
placebo-controlled Phase III clinical trial (n=161) that evaluated
the efficacy and safety of Iqirvo 80mg once daily plus UDCA (n=108)
versus placebo plus UDCA (n=53). Iqirvo or placebo was administered
in combination with UDCA in 95% of patients and as monotherapy in
5% of patients who were unable to tolerate UDCA. The 52-week study
was completed by 92% of participants with 97% of those who
completed the study continuing in an extension study. The results
were published in the New England Journal of Medicine3.
- The ELATIVE trial demonstrated that Iqirvo had a statistically
significant treatment benefit with 51% of patients on Iqirvo
achieving a biochemical response compared with 4% on the placebo
arm, a treatment benefit of 47% (95% CI 32, 57; p<0.0001).
Biochemical response was defined as ALP less than 1.67 Upper Limit
of Normal (ULN), an ALP decrease of greater than or equal to 15%
from baseline and total bilirubin (TB) ≤ ULN at week 52.
- ALP normalization at week 52 was a key secondary endpoint with
15% of Iqirvo-treated patients demonstrating normalization versus
0% placebo (p=0.002).
- The significant biochemical response to Iqirvo was further
supported by data demonstrating reductions from baseline in ALP
levels were sustained through week 52 and response was rapid, seen
as early as Week 4 in the Iqirvo group.
- The most common adverse reactions with Iqirvo reported in ≥ 10%
of study participants were weight gain, abdominal pain, diarrhea,
nausea and vomiting.
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, and in pre-commercialization, was demonstrated with the
success of the 52-week Phase 3 ELATIVE® study evaluating
elafibranor in 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
ABOUT IPSEN
Ipsen is a global biopharmaceutical company with a focus on
bringing transformative medicines to patients in three therapeutic
areas: Oncology, Rare Disease and Neuroscience. Ipsen’s
pipeline is fueled by external innovation and supported by nearly
100 years of development experience and global hubs in the U.S.,
France and the U.K. Its teams in more than 40 countries and its
partnerships around the world enable Ipsen to bring medicines to
patients in more than 80 countries. Ipsen is listed in Paris
(Euronext: IPN) and in the U.S. through a Sponsored Level I
American Depositary Receipt program (ADR: IPSEY). For more
information, visit ipsen.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, including, but not limited to statements about the
future development and commercialization of IQIVRO® by Ipsen, sales
thereof and financial projections regarding milestones and royalty
payments that GENFIT anticipates receiving. 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
PRESS RELATIONS | 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® and ELATIVE® are registered trademarks.
2 In December 2021, Ipsen acquired global rights
to develop and commercialize the molecule (except for China, Hong
Kong, Taiwan, and Macau, where Terns Pharmaceuticals holds the
exclusive license to develop and market elafibranor) 3
Kowdley. K.V, et al. Efficacy and Safety of Elafibranor in Primary
Biliary Cholangitis. NEJM. 2023. DOI: 10.1056/NEJMoa2306185
- GENFIT: Historic Milestone Achieved with U.S. FDA Accelerated
Approval of Ipsen’s Iqirvo® for Primary Biliary Cholangitis
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