SAN DIEGO, Nov. 29, 2016 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) today announced that the
Psychopharmacologic Drugs Advisory Committee of the U.S. Food and
Drug Administration (FDA) will review data included in the New Drug
Application (NDA) of INGREZZATM (valbenazine) for the
treatment of tardive dyskinesia on February
16, 2017. The FDA has granted Priority Review status to the
INGREZZA NDA with a Prescription Drug User Fee Act (PDUFA) target
action date of April 11, 2017.
The NDA for INGREZZA includes the results from the Kinect 2 and
Kinect 3 clinical trials which evaluated over 330 tardive
dyskinesia patients. Data from these studies along with the results
from another 18 clinical trials, extensive preclinical testing and
drug manufacturing data were included in the NDA submission.
About The Psychopharmacologic Drugs Advisory
Committee
The Committee is an independent panel of experts that reviews
and evaluates data concerning the safety and effectiveness of
marketed and investigational human drug products for use in the
practice of psychiatry and related fields and makes appropriate
recommendations to the FDA related to the drug product.
About Tardive Dyskinesia
Tardive dyskinesia is characterized by involuntary, repetitive
movements of the face, trunk, or extremities, including lip
smacking, grimacing, tongue protrusion, facial movements or
blinking, puckering and pursing of the lips. These symptoms are
rarely reversible and there are currently no FDA approved
treatments.
About INGREZZA
VMAT2 is a protein concentrated in the human brain that is
primarily responsible for re-packaging and transporting monoamines
(dopamine, norepinephrine, serotonin, and histamine) in
pre-synaptic neurons. INGREZZA (valbenazine or NBI-98854),
developed in the Neurocrine laboratories, is a novel,
highly-selective VMAT2 inhibitor that modulates dopamine release
during nerve communication, showing little or no affinity for
VMAT1, other receptors, transporters and ion channels. INGREZZA is
designed to provide low, sustained, plasma and brain concentrations
of active drug to allow for once daily dosing.
Modulation of neuronal dopamine levels in diseases such as
tardive dyskinesia, Tourette syndrome, Huntington's chorea,
schizophrenia, and tardive dystonia, which are characterized, in
part, by a hyperdopaminergic state, may provide symptomatic
benefits for patients with these diseases.
Neurocrine received Breakthrough Therapy Designation from the
FDA in 2014 for INGREZZA in the treatment of tardive dyskinesia.
The NDA for INGREZZA for the treatment of tardive dyskinesia is
currently under Priority Review with the FDA. The proprietary name
INGREZZA has been conditionally accepted by the FDA.
The Company is also investigating the safety and efficacy of
INGREZZA in the treatment of Tourette syndrome. The Company has two
ongoing placebo-controlled Phase II Tourette syndrome studies
evaluating INGREZZA in adults and pediatrics, the T-Forward study
and T-Force GREEN study, respectively. Each of these studies is
expected to enroll up to 90 subjects with Tourette syndrome.
Additionally, the Company has recently launched an open-label,
fixed-dose rollover study of INGREZZA in up to 180 subjects with
Tourette syndrome.
About Neurocrine Biosciences
Neurocrine Biosciences, Inc. discovers and develops innovative
and life-changing pharmaceuticals, in diseases with high unmet
medical needs, through its novel R&D platform, focused on
neurological and endocrine based diseases and disorders. The
Company's two lead late-stage clinical programs are elagolix, a
gonadotropin-releasing hormone antagonist for women's health that
is partnered with AbbVie Inc., and INGREZZA, a vesicular monoamine
transporter 2 inhibitor for the treatment of movement disorders.
Neurocrine plans to commercialize INGREZZA in the United States upon approval by the
FDA.
Neurocrine Biosciences, Inc. news releases are available through
the Company's website via the internet at
http://www.neurocrine.com.
In addition to historical facts, this press release contains
forward-looking statements that involve a number of risks and
uncertainties. Among the factors that could cause actual results to
differ materially from those indicated in the forward-looking
statements are risks and uncertainties associated with Neurocrine's
business and finances in general, as well as risks and
uncertainties associated with INGREZZA development. Specifically,
the risks and uncertainties the Company faces include risks that
the INGREZZA NDA may not obtain regulatory approval from the FDA
for tardive dyskinesia or such approval may be delayed or
conditioned; risks that additional regulatory submissions may not
occur or be submitted in a timely manner; risks that the FDA or regulatory authorities
outside the U.S. may make adverse decisions regarding INGREZZA;
risks that INGREZZA development activities for Tourette syndrome
may not be completed on time or at all; risks that ongoing INGREZZA
development activities may be delayed for regulatory or other
reasons; risks that ongoing or future INGREZZA clinical trials may
not be successful or replicate previous clinical trial results, may
fail to demonstrate that INGREZZA is safe, tolerable or effective,
or may not be predictive of real-world results or of results in
subsequent clinical trials; risks that INGREZZA may be
precluded from commercialization by the proprietary rights of third
parties, or have unintended side effects, adverse reactions or
incidents of misuse; risks associated with the Company's dependence
on third parties for development and manufacturing activities
related to INGREZZA; risks that the Company will be unable to raise
additional funding, if required, to complete development of or
commercialize INGREZZA; risks and uncertainties relating to
competitive products and technological changes that may limit
demand for INGREZZA; and other risks described in the Company's
quarterly report on Form 10-Q for the quarter ended September 30, 2016. Neurocrine disclaims any
obligation to update the statements contained in this press release
after the date hereof.
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SOURCE Neurocrine Biosciences, Inc.