WOODCLIFF LAKE, N.J. and
SAN DIEGO, July 19, 2016 /PRNewswire/ -- Eisai Inc. and
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that the
U.S. Food and Drug Administration (FDA) has approved the New Drug
Application (NDA) for BELVIQ XR® (lorcaserin HCl) CIV
extended-release 20 mg tablets. The new formulation of lorcaserin
will offer patients a once-a-day dosing option that may help them
achieve and maintain weight loss. BELVIQ XR is expected to be
available in the fall of 2016. In connection with the approval,
Arena will receive a $10 million
milestone payment.
BELVIQ XR is proven to be slowly absorbed in the body and lasts
throughout the day. Both the original 10 mg twice-daily formulation
of BELVIQ and newly-approved 20 mg once-daily extended release
formulation are approved for use with 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 or BELVIQ XR, when taken with other prescription,
over-the-counter, or herbal weight-loss products, is safe and
effective. It is not known if BELVIQ or BELVIQ XR changes your risk
of heart problems, stroke, or death due to heart problems or
stroke.
"With approximately two-thirds of the U.S. population living
with extra weight or obesity, there is a significant and growing
need to address chronic weight management," said Louis J. Aronne, M.D., Director of the
Comprehensive Weight Control Center at Weill Cornell Medicine,
physician at NewYork-Presbyterian/Weill Cornell Medical Center
and Principal Investigator of the BELVIQ clinical trials. "Having a
once-daily treatment may offer an option for patients to stay on
track to meet their weight loss goals."
The bioequivalence and bioavailability of once-daily BELVIQ XR
20 mg compared with twice-daily BELVIQ 10 mg was based on two Phase
1 registrational clinical trials among healthy adult
subjects. The most common treatment-emergent adverse events
were similar to those seen in the Phase 3 clinical trials of BELVIQ
10 mg twice-daily.
"We're excited to offer this once-a-day option of lorcaserin,"
said Andrew Satlin, M.D., Executive
Vice President, Neurology Business Group, Eisai Inc. "This option
may provide another choice for patients who are overweight or obese
and find it difficult to lose weight through diet and exercise
alone. The development of this new formulation further underscores
Eisai's ongoing commitment to help address the health care needs of
this underserved population."
"We are pleased that once-daily BELVIQ XR has been approved by
the FDA and will provide patients another option for weight loss,"
said Amit D. Munshi, Arena's
President and Chief Executive Officer. "The approval of this new
formulation is another example of Arena's success in supporting our
collaborators."
What are BELVIQ® and BELVIQ XR®?
BELVIQ® and BELVIQ XR® are FDA-approved
prescription weight-loss medications that, when used with diet and
exercise, can help some overweight (Body Mass Index [BMI] ≥27
kg/m2) adults with a weight-related medical
problem, or obese (BMI ≥30 kg/m²) adults, lose weight and
keep it off.
It is not known if BELVIQ or BELVIQ XR when taken with other
prescription, over-the-counter, or herbal weight-loss
products is safe and effective. It is not known if BELVIQ or
BELVIQ XR changes your risk of heart problems, stroke, or death due
to heart problems or stroke.
Important Safety Information
- Pregnancy: Do not take if you are pregnant or
planning to become pregnant, as weight loss offers no potential
benefit during pregnancy and BELVIQ or BELVIQ XR may harm your
unborn baby.
- Hypersensitivity Reactions: Do not take if you are
allergic to either of these medicines or any of their
ingredients.
- Serotonin Syndrome or Neuroleptic Malignant Syndrome
(NMS)-like reactions: Before using, tell your doctor about
all the medicines you take, especially medicines that treat
depression, migraines, mental problems, or the common cold. These
medicines may cause serious or life-threatening side effects if
taken with BELVIQ or BELVIQ XR. Call your doctor right away if you
experience agitation, hallucinations, confusion, or other changes
in mental status; coordination problems; uncontrolled muscle
spasms; muscle twitching; restlessness; racing or fast heartbeat;
high or low blood pressure; sweating; fever; nausea; vomiting;
diarrhea; or stiff muscles.
- Valvular heart disease: Some people taking
medicines like BELVIQ or BELVIQ XR have had heart valve problems.
Call your doctor right away if you experience trouble breathing;
swelling of the arms, legs, ankles, or feet; dizziness, fatigue, or
weakness that will not go away; or fast or irregular heartbeat.
Before taking BELVIQ or BELVIQ XR, tell your doctor if you have or
have had heart problems.
- Changes in attention or memory: BELVIQ or BELVIQ XR
may slow your thinking. You should not drive a car or operate heavy
equipment until you know how BELVIQ or BELVIQ XR affects you.
- Mental problems: Taking too much BELVIQ or BELVIQ
XR may cause hallucinations, a feeling of being high or in a very
good mood, or feelings of standing outside your body.
- Depression or thoughts of suicide: Call your doctor
right away if you notice any mental changes, especially sudden
changes in your mood, behaviors, thoughts, or feelings, or if you
have depression or thoughts of suicide.
- Low blood sugar: Weight loss can cause low blood
sugar in people taking medicines for type 2 diabetes, such as
insulin or sulfonylureas. Blood sugar levels should be checked
before and while taking BELVIQ or BELVIQ XR. Changes to diabetes
medication may be needed if low blood sugar develops.
- Painful erections: If you have an erection lasting
more than 4 hours while on BELVIQ or BELVIQ XR, stop taking BELVIQ
or BELVIQ XR and call your doctor or go to the nearest emergency
room right away.
- Slow heartbeat: Both BELVIQ or BELVIQ XR may cause
your heart to beat slower.
- Decreases in blood cell count: BELVIQ or BELVIQ XR
may cause your red and white blood cell counts to decrease.
- Increase in prolactin: BELVIQ or BELVIQ XR may
increase the amount of a hormone called prolactin. Tell your doctor
if your breasts begin to make milk or a milky fluid, or if you are
a male and your breasts increase in size.
- Most common side effects of BELVIQ® or BELVIQ
XR® : headache, dizziness, fatigue, nausea, dry
mouth, constipation, cough, low blood sugar (hypoglycemia) in
patients with diabetes, and back pain.
- Nursing: BELVIQ or BELVIQ XR should not be taken
while breastfeeding.
- Drug interactions: Before taking BELVIQ or BELVIQ
XR, tell your doctor if you take medicines for depression,
migraines, or other medical conditions, such as: triptans;
medicines used to treat mood, anxiety, psychotic or thought
disorders, including tricyclics, lithium, selective serotonin
reuptake inhibitors, selective serotonin-norepinephrine reuptake
inhibitors, monoamine oxidase inhibitors, or antipsychotics;
cabergoline; linezolid (an antibiotic); tramadol; dextromethorphan
(an over-the-counter (OTC) common cold/cough medicine); OTC
supplements such as tryptophan or St. John's Wort; or erectile
dysfunction medicines.
BELVIQ and BELVIQ XR are federally controlled substances (CIV)
because they may be abused or lead to drug dependence.
For more information about BELVIQ®, talk to your
doctor and see the full Product Information.
For more information about BELVIQ XR®, talk to
your doctor and see the full Product
Information.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We
give our first thoughts to patients and their families, and helping
to increase the benefits health care provides. As the U.S.
pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a
passionate commitment to patient care that is the driving force
behind our efforts to discover and develop innovative therapies to
help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that
operates in two global business groups: oncology and
neurology (dementia-related diseases and neurodegenerative
diseases). Each group functions as an end-to-end global business
with discovery, development, manufacturing, and marketing
capabilities. Our U.S. headquarters, commercial and clinical
development organizations are located in New Jersey; our discovery labs are in
Massachusetts and Pennsylvania; and our global demand chain
organization resides in Maryland
and North Carolina. To learn more
about Eisai Inc., please visit us at www.eisai.com/US.
About Arena Pharmaceuticals
We are a biopharmaceutical company focused on discovering and
developing novel, small molecule drugs. We are currently directing
our activities and resources primarily on the following
activities:
- Advancing our proprietary clinical programs:
- Etrasimod (APD334) – a next generation, highly specific
modulator of Sphingosine 1-Phosphate Subtype 1 (S1P1)
receptor – in an ongoing Phase 2 clinical trial for ulcerative
colitis, and potentially exploring additional indications,
including beyond inflammatory bowel disease
- Ralinepag (APD811) – an agonist of the prostacyclin receptor –
in an ongoing Phase 2 clinical trial for pulmonary arterial
hypertension (PAH)
- APD371 – an agonist of the cannabinoid-2 (CB2)
receptor – most recently completed a Phase 1 multiple-ascending
dose clinical trial with favorable results, and is under evaluation
for pain indications
- Supporting our collaborations:
- Eisai Inc. and Eisai Co., Ltd. and others – in their
efforts with respect to the approved product lorcaserin HCl for
weight management
- Axovant Sciences Ltd. – in Phase 2 clinical trials for
nelotanserin, an inverse agonist of the serotonin 2A receptor for
central nervous system disorders
- Ildong Pharmaceuticals Co., Ltd. – in a Phase 1 clinical trial
for temanogrel, an inverse agonist of the serotonin 2A receptor for
thrombotic diseases
- Boehringer Ingelheim International GmbH – in preclinical
development of drug candidates targeting a central nervous system
(CNS) receptor for psychiatric diseases
Our US operations are located in San
Diego, California, and our operations outside of
the United States, including our
commercial manufacturing facility, are 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; the need to address obesity; the
achievement of a milestone; Eisai's commitment; Arena's success in
supporting its collaborators; and Arena's focus, plans, goals,
strategy, expectations, research and development programs, and
ability to 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: risks
related to commercializing drugs, including regulatory,
manufacturing, supply and marketing issues and the availability and
use of BELVIQ and BELVIQ XR; cash and revenues generated from
BELVIQ and BELVIQ XR; Arena may need additional funds to advance
all of its programs, and you may not agree with the manner Arena
allocates its resources; 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 BELVIQ or BELVIQ XR 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; 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.
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SOURCE Eisai