Minerva Neurosciences Announces the NDA Filing for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
01 Maio 2023 - 8:00AM
Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage
biopharmaceutical company focused on the development of therapies
to treat central nervous system (CNS) disorders, today announced
that the U.S. Food and Drug Administration (FDA) filed the
Company’s New Drug Application (NDA) for roluperidone for the
treatment of negative symptoms in patients with schizophrenia on
April 27, 2023. The decision to file the NDA follows the Company’s
request for formal dispute resolution and appeal of FDA’s October
2022 refuse to file letter. The issues cited in the refuse-to-file
decision included those discussed at the type C meeting in April
2022. In granting the appeal, the FDA deciding official agreed
with the Company that the issues cited in the refuse-to-file
decision should be considered during FDA’s review of the NDA.
“We thank the FDA for its thoughtful review and consideration of
our materials submitted during the formal dispute resolution
process. We look forward to continuing to work with the FDA with
the ultimate goal of obtaining approval of roluperidone as the
first approved treatment for negative symptoms of schizophrenia for
the benefit of patients, their families, caregivers, and
physicians,” said Dr. Remy Luthringer, Executive Chairman and Chief
Executive Officer of Minerva.
“Negative symptoms are a major source of disability in people
with schizophrenia and there have been no approved treatments to
date. An approved treatment for negative symptoms could
revolutionize the treatment of schizophrenia and would certainly
have a major impact on the quality of life of the millions of
people affected with this disease,” said Dr. Philip Harvey, Leonard
M. Miller Professor of Psychiatry and Behavioral Sciences and
Director of the Division of Psychology at
the University of Miami Miller School of Medicine.
About Schizophrenia and Negative
SymptomsSchizophrenia is a chronic, severe, and
debilitating type of mental illness characterized by distortions in
thinking, perception, emotions, language, sense of self and
behavior. Schizophrenia affects 20 million people worldwide. (World
Health Organization).
Negative symptoms can cause individuals with schizophrenia to
withdraw from society, become disinterested or unable to complete
tasks or feel pleasure. Negative symptoms are characterized by five
constructs: blunted affect, alogia, avolition, anhedonia, and
asociality (Marder and Galderisi, 2017).
Negative symptoms are the main cause of the poor functional
outcome of patients suffering from schizophrenia (Harvey et al.,
2020) and may also be one of the main reasons ultra-high risk
adolescents may develop full blown schizophrenia (Gomes and Grace,
2017). There are currently no treatments approved for negative
symptoms of schizophrenia in the US.
Minerva believes that research continues to emerge indicating
that there is a large subgroup of patients with schizophrenia who
have moderate to severe primary negative symptoms and minimal
positive symptoms (Galderisi 2021) and have a low risk of
worsening of positive symptoms even in the absence of antipsychotic
treatments (Harrow 2013; Moilanen 2016;
Murray 2016; Wils 2017; Wunderink 2013;
Landolt 2016).
About Minerva Neurosciences
Minerva Neurosciences, Inc. (Nasdaq: NERV) is a
clinical-stage biopharmaceutical company focused on developing
product candidates to treat central nervous system (CNS) diseases.
Our goal is to transform the lives of patients with improved
therapeutic options. Minerva’s portfolio of compounds includes
roluperidone (MIN-101), in clinical development for negative
symptoms of schizophrenia, and MIN-301 for Parkinson’s
disease. For more information, please visit our website.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are
subject to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts, reflect
management’s expectations as of the date of this press release, and
involve certain risks and uncertainties. These statements may be
identified by words such as “aims,” “anticipates,” “believes,”
“could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,”
“may,” “plans,” “possible,” “potential,” “seeks,” “will” and
variations of these words or similar expressions that are intended
to identify forward-looking statements, although not all
forward-looking statements contain these words. Forward-looking
statements include, but are not limited to, statements herein with
respect to the regulatory progress and therapeutic potential of
roluperidone for the treatment of negative symptoms in patients
with schizophrenia. These forward-looking statements are based on
our current expectations and may differ materially from actual
results due to a variety of factors including, without limitation,
whether the FDA will require additional trials or data which may
significantly delay and put at risk our efforts to obtain
regulatory approval; whether the FDA may meet expected review
timelines for our NDA; whether roluperidone will be successfully
marketed if approved; management’s ability to successfully achieve
its goals; our ability to raise additional capital to fund our
operations and corporate objectives on terms acceptable to us;
general economic conditions; and other factors that are described
under the caption “Risk Factors” in our filings with the Securities
and Exchange Commission, including our Annual Report on Form 10-K
for the year ended December 31, 2022, filed with
the Securities and Exchange Commission on March 8, 2023.
Copies of reports filed with the SEC are posted on our
website at www.minervaneurosciences.com. The forward-looking
statements in this press release are based on information available
to us as of the date hereof, and we expressly disclaim any
obligation to update any forward-looking statements, except as
required by law.
Contacts:
Investor inquiries:
Frederick AhlholmChief Financial OfficerMinerva
Neurosciences, Inc.Info@minervaneurosciences.com
Media inquiries:
Helen ShikPrincipalShik Communications
LLCHelen@ShikCommunications.com
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