Fanapt® Treatment is Now Available
to Adult Patients for the Acute Treatment of Manic or Mixed
Episodes Associated with Bipolar I Disorder
Approval Represents Significant Novel
Indication for Vanda's Fanapt® Franchise
WASHINGTON, April 2,
2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc.
(Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug
Administration (FDA) has approved Fanapt® (iloperidone)
tablets for the acute treatment of manic or mixed episodes
associated with bipolar I disorder in
adults. Fanapt® is an atypical antipsychotic agent
that has been used for the acute treatment of patients with
schizophrenia since its FDA approval in 2009.
"Manic or mixed episodes associated with bipolar I disorder are
highly complex conditions, which require a host of trusted options
to meet individual patient needs. With over 100,000 patient years
of experience, Fanapt is a familiar therapeutic agent that offers
flexible dosing with a well-known safety profile. This FDA approval
gives patients and service providers a new treatment option for
managing bipolar I disorder," said Mihael H. Polymeropoulos M.D., Vanda's
President, CEO and Chairman of the Board.
Bipolar disorder is a serious, highly prevalent psychiatric
chronic condition affecting approximately 2.8% of the U.S. adult
population, with 83% of them classified as severe1.
Bipolar disorder is a group of disorders that are characterized by
periods of elevated mood alternating with periods of depressed
mood. For the diagnosis of bipolar I disorder, people must have
experienced one or more episodes of mania and most would have
episodes of both mania and depression. Patients with bipolar I
disorder with manic or mixed episodes are a subset of those
approximately 10 million Americans with bipolar
disorder1. The marketing approval of
Fanapt® in bipolar I disorder with manic and mixed
episodes significantly increases the commercial opportunity for
Fanapt®.
Stephen Stahl, MD, PhD, Professor
of Psychiatry at the University of California
San Diego, said, "Many patients today are still unable to
find suitable treatment options for effectively managing bipolar
disorder. Tailoring the right treatment for the right patient is
critical for effective care, and the approval of Fanapt represents
an important milestone. Fanapt possesses a well-studied safety
profile, and its approval will provide patients with a new and
effective option for treating a highly complex disorder."
The approval of Fanapt® for the acute treatment of
adults with manic or mixed episodes associated with bipolar I
disorder was based on a pivotal study randomizing approximately 400
patients. The primary endpoint measured in Week 4 of treatment was
assessed by the Young Mania Rating Scale (YMRS), a rating scale of
clinical severity in the core symptoms of mania. At the end of the
study (Week 4), Fanapt® treated patients showed a
larger improvement than placebo treated patients, and this
difference was highly statistically significant (p=0.000008). YMRS
was assessed at the end of Weeks 1, 2, 3 and 4. Statistically
significant benefit in the Fanapt® treated group
over placebo was observed as early as the Week 2 assessment. The
safety profile of Fanapt® in this study was similar to
that seen in Fanapt® studies previously conducted for
the treatment of schizophrenia in adults.
Dr. Polymeropoulos continued, "Today's announcement marks a
significant step forward for one of Vanda's leading franchises and
underscores the effectiveness of our strategy in pursuing
innovative therapies that address high unmet medical needs to
improve the lives of patients. With this as our foundation, we have
established a resilient business, with a diverse product pipeline,
a history of revenue growth and strong financial position. We
remain focused on providing critical medicines to patients across
the world while creating sustainable, long-term value."
References:
- Harvard Medical School, 2007.
National Comorbidity Survey (NSC). (2017, August 21). Retrieved from
https://www.hcp.med.harvard.edu/ncs/index.php
About Vanda Pharmaceuticals Inc.
Vanda is a leading
global biopharmaceutical company focused on the development and
commercialization of innovative therapies to address high unmet
medical needs and improve the lives of patients. For more on Vanda
Pharmaceuticals Inc., please visit www.vandapharma.com and
follow us on X @vandapharma.
About Fanapt®
For full U.S. Prescribing
Information for Fanapt®, including indication, Boxed
Warnings and Important Safety Information, visit our Web site at
www.fanapt.com.
INDICATION AND IMPORTANT SAFETY
INFORMATION
Fanapt® (iloperidone) is indicated
for the treatment of schizophrenia in adults and the acute
treatment of manic or mixed episodes associated with bipolar I
disorder in adults. Titrate the dosage of Fanapt® to
avoid orthostatic hypotension.
BOXED WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS:
Elderly patients with
dementia-related psychosis treated with antipsychotic drugs are at
an increased risk of death. Fanapt® is not approved for
use in patients with dementia-related psychosis.
CONTRAINDICATIONS
- Known hypersensitivity to Fanapt® or to any
components in the formulation. Anaphylaxis, angioedema, and other
hypersensitivity reactions have been reported.
WARNING AND PRECAUTIONS
- In placebo-controlled trials in elderly subjects with dementia,
patients randomized to risperidone, aripiprazole, and olanzapine
had a higher incidence of stroke and transient ischemic attack,
including fatal stroke. See boxed warning.
- QT prolongation: Fanapt® prolongs QT interval and
may be associated with arrhythmia and sudden death. Avoid use of
Fanapt® in combination with other drugs that are known
to prolong QTc; use caution and consider dose modification when
prescribing Fanapt® with other drugs that inhibit
Fanapt® metabolism. Monitor serum potassium and
magnesium in patients at risk for electrolyte disturbances.
- Neuroleptic malignant syndrome, a potentially fatal symptom,
has been reported in association with antipsychotic drugs including
Fanapt®. Manage with immediate discontinuation of drug,
treatment if needed, and close monitoring.
- Tardive dyskinesia: The risk of tardive dyskinesia may increase
as the duration of treatment and total cumulative dose increases.
Discontinue Fanapt® if clinically appropriate.
- Metabolic changes: Atypical antipsychotic drugs have been
associated with metabolic changes that may increase
cardiovascular/cerebrovascular risk. These metabolic changes
include hyperglycemia, dyslipidemia, and weight gain.
Hyperglycemia, in some cases extreme and associated with
ketoacidosis, hyperosmolar coma or death, has been reported in
patients treated with antipsychotics. Weight gain has been
reported. Monitor glucose, lipids, and weight when starting
Fanapt® and thereafter.
- Seizures: Use Fanapt® cautiously in patients with a
history of seizures or with conditions that lower seizure
threshold.
- Orthostatic hypotension: Dizziness, tachycardia, and syncope
can occur with standing. More rapid titration would be expected to
increase the rate of orthostatic hypotension and syncope.
- Fanapt® may cause somnolence, postural hypotension,
motor and sensory instability, which may lead to falls causing
fractures or other injuries. For patients with diseases,
conditions, or medications that could exacerbate these effects,
complete fall risk assessments initially and recurrently during
therapy.
- Leukopenia, neutropenia, and agranulocytosis have been reported
with antipsychotics. Patients with a pre-existing low white blood
cell count (WBC) or a history of leukopenia/neutropenia should have
their complete blood count (CBC) monitored frequently during the
first few months of therapy and should discontinue
Fanapt® at the first sign of a decline in WBC in the
absence of other causative factors.
- Hyperprolactinemia: As with other drugs that antagonize
dopamine D2 receptors, Fanapt® elevates prolactin
levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have
been reported with prolactin-elevating compounds.
- Body temperature regulation: Appropriate care is advised when
prescribing Fanapt® for patients who will be
experiencing conditions which may contribute to an elevation in
core body temperature.
- Dysphagia: Esophageal dysmotility and aspiration have been
associated with antipsychotic drug use. Fanapt® should
be used cautiously in patients at risk for aspiration pneumonia,
including the elderly and those with advanced Alzheimer's
dementia.
- Priapism: Cases have been reported in association with
Fanapt® treatment.
- Potential for cognitive and motor impairment: Use caution when
operating machinery.
- Intraoperative floppy iris syndrome (IFIS): IFIS has been
observed in some patients treated with alpha-1 adrenergic blockers.
Instruct patients to tell their ophthalmologist about their use of
Fanapt® before cataract or glaucoma surgery.
ADVERSE REACTIONS
- Commonly observed adverse reactions (incidence ≥5% and 2-fold
greater than placebo) were:
- Schizophrenia: dizziness, dry mouth, fatigue, nasal congestion,
orthostatic hypotension, somnolence, tachycardia, and weight
increased.
- Bipolar mania: tachycardia, dizziness, dry mouth, hepatic
enzymes increased, nasal congestion, weight increased, hypotension,
and somnolence.
DRUG INTERACTIONS
- The dose of Fanapt® should be reduced by one-half in
patients co-administered a strong CYP2D6 or CYP3A4 inhibitor.
USE IN SPECIFIC POPULATIONS
- Fanapt® may cause extrapyramidal symptoms and/or
withdrawal symptoms in neonates with third trimester exposure.
Nursing mothers are advised not to breastfeed while taking
Fanapt®.
- The safety and effectiveness of Fanapt® has not been
established in children and adolescents.
- Fanapt® is not recommended for patients with severe
hepatic impairment.
- The dose of Fanapt® should be reduced by one-half in
patients who are poor metabolizers of CYP2D6.
Please see full Prescribing Information, including BOXED
WARNING.
CAUTIONARY NOTE REGARDING FORWARD LOOKING
STATEMENTS
Various statements in this release, including,
but not limited to statements regarding Vanda's ability to make
Fanapt® available to patients with manic or mixed
episodes associated with bipolar I disorder and the commercial
opportunity for Fanapt®, are "forward-looking
statements" under the securities laws. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. Forward-looking statements are based
upon current expectations and assumptions that involve risks,
changes in circumstances and uncertainties. Important factors that
could cause actual results to differ materially from those
reflected in Vanda's forward-looking statements include, among
others, market acceptance of Fanapt® as an acute
treatment for adults with manic or mixed episodes associated with
bipolar I disorder, Vanda's dependence on third-party manufacturers
to manufacture Fanapt® in sufficient quantities and
quality, and the effectiveness of Vanda's sales and marketing
infrastructure. Therefore, no assurance can be given that the
results or developments anticipated by Vanda will be realized or,
even if substantially realized, that they will have the expected
consequences to, or effects on, Vanda. Forward-looking statements
in this press release should be evaluated together with the various
risks and uncertainties that affect Vanda's business and market,
particularly those identified in the "Cautionary Note Regarding
Forward-Looking Statements", "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" sections of Vanda's most recent Annual Report on Form
10-K, as updated by Vanda's subsequent Quarterly Reports on Form
10-Q, Current Reports on Form 8-K and other filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov.
All written and verbal forward-looking statements attributable
to Vanda or any person acting on its behalf are expressly qualified
in their entirety by the cautionary statements contained or
referred to herein. Vanda cautions investors not to rely too
heavily on the forward-looking statements Vanda makes or that are
made on its behalf. The information in this press release is
provided only as of the date of this press release, and Vanda
undertakes no obligation, and specifically declines any obligation,
to update or revise publicly any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law.
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
Jim Golden / Jack Kelleher / Dan
Moore
Collected Strategies
VANDA-CS@collectedstrategies.com
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SOURCE Vanda Pharmaceuticals Inc.