WOODCLIFF LAKE, N.J. and
SAN DIEGO, Nov. 30, 2015 /PRNewswire/ -- Eisai Inc. and
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that the
U.S. Food and Drug Administration (FDA) has accepted for filing the
New Drug Application (NDA) for an extended release formulation of
lorcaserin. If approved, the extended release formulation will
offer patients a chronic weight management treatment in a
once-daily dosing option.
Lorcaserin (sold under the brand name BELVIQ®) is
currently approved as an adjunct to a reduced-calorie diet and
increased physical activity for chronic weight management in adults
who have a body mass index (BMI) of 30 kg/m2 or greater
(obese), or BMI of 27 kg/m2 or greater (overweight) with
at least one weight-related medical condition, such as high blood
pressure, high cholesterol, or type 2 diabetes. It is not known if
BELVIQ is safe and effective when taken with other prescription,
over-the-counter, or herbal weight loss products, nor is it known
if BELVIQ changes the risk of heart problems or stroke, or death
due to heart problems or stroke.
"The filing of this application by the FDA means they have made
a threshold determination that it is sufficiently complete to
permit a substantive review," said Craig M.
Audet, Ph.D., Arena's Senior Vice President of Operations
& Head of Global Regulatory Affairs. "This extended
release formulation has the potential to offer patients once-daily
dosing of lorcaserin, which can be an important addition to their
chronic weight management plan."
The regulatory filing for the extended release formulation is
based on the results of two Phase 1 registrational clinical trials
evaluating bioequivalence of a once-daily, 20 mg extended release
formulation of lorcaserin, as compared to the currently approved,
twice-daily 10 mg immediate release formulation. If approved,
the extended release formulation is expected to be marketed as
BELVIQ XR®, which is the brand name conditionally
approved by the FDA.
"The dramatic rise in obesity has major consequences for public
health," said Frank Ciriello,
President, Eisai Global Neurology Business Unit and Established
Products. "If approved, this once-a-day option will provide another
choice for appropriate patients who find it difficult to lose
weight through diet and exercise alone."
Lorcaserin is believed to decrease food consumption and promote
satiety by selectively activating the serotonin 2C receptors in the
brain.
The extended release formulation of lorcaserin is
investigational and not approved by any regulatory agency.
About BELVIQ® (lorcaserin HCl) CIV
Immediate-release lorcaserin is approved under the brand name
BELVIQ for weight management by the FDA and the Ministry of Food
and Drug Substances in South
Korea. Eisai Inc. and Ildong Pharmaceutical Co., Ltd.,
market and distribute BELVIQ in the
United States and South
Korea, respectively, and Arena manufactures and supplies the
finished commercial product from its facility in Switzerland.
Important Safety Information
Contraindication
- BELVIQ should not be taken during pregnancy or by women who are
planning to become pregnant.
Warnings and Precautions
- BELVIQ is a serotonergic drug. The development of potentially
life-threatening serotonin syndrome or Neuroleptic Malignant
Syndrome (NMS)-like reactions have been reported during use of
serotonergic drugs, including, but not limited to, selective
serotonin-norepinephrine reuptake inhibitors, and selective
serotonin reuptake inhibitors, tricyclic antidepressants,
bupropion, triptans, dietary supplements such as St. John's Wort
and tryptophan, drugs that impair metabolism of serotonin
(including monoamine oxidase inhibitors), dextromethorphan,
lithium, tramadol, antipsychotics or other dopamine antagonists,
particularly when used in combination. Patients should be monitored
for the emergence of serotonin syndrome symptoms or NMS-like
reactions, including agitation, hallucinations, coma, tachycardia,
labile blood pressure, hyperthermia, hyperreflexia, incoordination,
nausea, vomiting, diarrhea, and muscle rigidity. Treatment with
BELVIQ and any concomitant serotonergic or antidopaminergic agents
should be discontinued immediately if the above events occur, and
supportive symptomatic treatment should be initiated.
- Patients should not take BELVIQ in combination with drugs that
have been associated with valvular heart disease (e.g.,
cabergoline). In clinical trials, 2.4% of patients taking BELVIQ
and 2.0% of patients taking placebo developed valvular
regurgitation: none of these patients was symptomatic. BELVIQ
should be used with caution in patients with congestive heart
failure (CHF). Patients who develop signs and symptoms of valvular
heart disease, including dyspnea, dependent edema, CHF, or a new
cardiac murmur, should be evaluated and discontinuation of BELVIQ
should be considered.
- Impairment in attention, memory, somnolence, confusion, and
fatigue, have been reported in patients taking BELVIQ. Patients
should not drive a car or operate heavy machinery until they know
how BELVIQ affects them.
- The recommended dose of 10 mg twice daily should not be
exceeded, as higher doses may cause euphoria, hallucination, and
dissociation. Monitor patients for the development or worsening of
depression, suicidal thoughts or behaviors, and/or any changes in
mood. Discontinue BELVIQ in patients who develop suicidal thoughts
or behaviors.
- Weight loss may increase the risk of hypoglycemia in patients
with type 2 diabetes mellitus who are being treated with
antidiabetic medications, so measurement of blood sugar levels
before and during treatment with BELVIQ is recommended. Decreases
in doses of antidiabetic medications or changes in medication
regimen should be considered.
- Men who experience priapism should immediately discontinue
BELVIQ and seek emergency medical attention. BELVIQ should be used
with caution with erectile dysfunction medications. BELVIQ should
be used with caution in men who have conditions that might
predispose them to priapism (e.g., sickle cell anemia, multiple
myeloma, or leukemia), or in men with anatomical deformation of the
penis (e.g., angulation, cavernosal fibrosis, or Peyronie's
disease).
- Because BELVIQ may cause a slow heartbeat, it should be used
with caution in patients with a history of bradycardia or heart
block greater than first degree.
- Consider monitoring for CBC changes, prolactin excess, and
pulmonary hypertension.
Most Common Adverse Reactions
- In patients without diabetes: headache (17%), dizziness (9%),
fatigue (7%), nausea (8%), dry mouth (5%), and constipation
(6%).
- In patients with diabetes: hypoglycemia (29%), headache (15%),
back pain (12%), cough (8%), and fatigue (7%).
Nursing Mothers
- BELVIQ should not be taken by women who are nursing.
BELVIQ® is a federally controlled substance (CIV)
because it may be abused or lead to drug dependence.
For more information about BELVIQ, click here for the full
Product Information or visit www.BELVIQ.com.
About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We
give our first thoughts to patients and their families. As the U.S.
pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., our passionate
commitment to patient care is the driving force. We are a fully
integrated pharmaceutical business with discovery, clinical,
manufacturing and marketing capabilities. Our key areas of
commercial focus include oncology and specialty care (Alzheimer's
disease, epilepsy and metabolic disorders). To learn more about
Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product
creation organization that includes R&D facilities in
Massachusetts, New Jersey and Pennsylvania, as well as a global demand chain
organization that includes manufacturing infrastructure in
Maryland and North Carolina. Eisai's global areas of
R&D focus include neuroscience; oncology; metabolic disorders;
vascular, inflammatory and immunological reaction; and
antibody-based programs.
About Arena Pharmaceuticals
Arena embraces the challenge of improving health by seeking to
bring innovative medicines targeting G protein-coupled receptors to
patients. Arena's focus is discovering, developing and
commercializing drugs to address unmet medical needs, and
BELVIQ® (lorcaserin HCl) is Arena's first internally
discovered drug approved for marketing. Arena has US operations
located in San Diego, California, and operations outside of the
United States, including its
commercial manufacturing facility, located in Zofingen,
Switzerland. For more information,
visit Arena's website at www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are
registered service marks of Arena Pharmaceuticals, Inc.
BELVIQ® and BELVIQ XR® are registered
trademarks of Arena Pharmaceuticals GmbH.
Forward-Looking Statements
Certain statements in this press release are forward-looking
statements that involve a number of risks and uncertainties. Such
forward-looking statements include statements about the therapeutic
indication, use, safety, efficacy, mechanism of action and
potential of BELVIQ and BELVIQ XR, including the potential of
BELVIQ XR to offer once-daily dosing; the meaning and significance
of the filing of the NDA for BELVIQ XR; the potential approval and
marketing of an extended release formulation of lorcaserin,
including under the brand name BELVIQ XR; the results of the
registrational trials of BELVIQ XR, including their support of the
NDA for BELVIQ XR; the manufacture, supply, marketing and
distribution of BELVIQ; embracing the challenge of improving
health; seeking to bring innovative medicines to patients; and
Arena's focus, plans, goals, strategy, expectations, research and
development programs, and ability to discover and develop compounds
and commercialize drugs. For such statements, Arena claims the
protection of the Private Securities Litigation Reform Act of 1995.
Actual events or results may differ materially from Arena's
expectations. Factors that could cause actual results to differ
materially from the forward-looking statements include, but are not
limited to, the following: the FDA (or any other regulatory agency)
may not agree that bioequivalence has been established for BELVIQ
XR or ever approve any regulatory application for an extended
release formulation of lorcaserin; risks related to commercializing
drugs, including regulatory, manufacturing, supply and marketing
issues and the availability and use of BELVIQ or lorcaserin; cash
and revenues generated from BELVIQ; the risk that Arena's revenues
are based in part on estimates, judgment and accounting policies,
and incorrect estimates or disagreement regarding estimates or
accounting policies may result in changes to Arena's guidance or
previously reported results; the timing and outcome of regulatory
review is uncertain, and lorcaserin may not receive any additional
marketing approvals; regulatory decisions in one territory may
impact other regulatory decisions and Arena's business prospects;
government and commercial reimbursement and pricing decisions;
risks related to relying on collaborative arrangements; the timing
and receipt of payments and fees, if any, from collaborators; the
entry into or modification or termination of collaborative
arrangements; unexpected or unfavorable new data; nonclinical and
clinical data is voluminous and detailed, and regulatory agencies
may interpret or weigh the importance of data differently and reach
different conclusions than Arena or others, request additional
information, have additional recommendations or change their
guidance or requirements before or after approval; data and other
information related to any of Arena's research and development may
not meet regulatory requirements or otherwise be sufficient for (or
Arena or a collaborator may not pursue) further research and
development, regulatory review or approval or continued marketing;
Arena's and third parties' intellectual property rights; the
timing, success and cost of Arena's research and development and
related strategy and decisions; results of clinical trials and
other studies are subject to different interpretations and may not
be predictive of future results; clinical trials and other studies
may not proceed at the time or in the manner expected or at all;
having adequate funds; and satisfactory resolution of litigation or
other disagreements with others. Additional factors that could
cause actual results to differ materially from those stated or
implied by Arena's forward-looking statements are disclosed in
Arena's filings with the Securities and Exchange Commission. These
forward-looking statements represent Arena's judgment as of the
time of this release. Arena disclaims any intent or obligation to
update these forward-looking statements, other than as may be
required under applicable law.
Contacts: Eisai
Inc.
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Investor
Inquiries:
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Media
Inquiries:
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Alex
Scott
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Laurie
Landau
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alex_scott@eisai.com
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Laurie_Landau@eisai.com
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201.746.2177
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201.746.2510
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Contact: Arena
Pharmaceuticals, Inc.
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Craig M. Audet,
Ph.D.,
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Senior Vice
President,
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Operations & Head
of Global
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Regulatory
Affairs
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caudet@arenapharm.com
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858.453.7200 ext.
1612
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www.eisai.com/US
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www.arenapharm.com
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visit:http://www.prnewswire.com/news-releases/eisai-and-arena-pharmaceuticals-announce-fda-acceptance-of-new-drug-application-for-extended-release-formulation-of-lorcaserin-300185100.html
SOURCE Eisai Inc.; Arena Pharmaceuticals, Inc.