- FDA Sets PDUFA Target Action Date of June 1, 2021 -
DUBLIN, Dec. 29, 2020 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today announced that the U.S. Food and Drug
Administration (FDA) has acknowledged receipt of the company's New
Drug Application (NDA) resubmission for ALKS 3831
(olanzapine/samidorphan) for the treatment of adults with
schizophrenia and adults with bipolar I disorder, and has assigned
the application a new Prescription Drug User Fee Act (PDUFA) target
action date of June 1, 2021.
The FDA classified the resubmission as a complete, Class 2
response to the Complete Response Letter (CRL) issued in
November 2020, following a remote
review of records requested under Section 704(a)(4) of the Federal
Food, Drug, and Cosmetic Act (the "FDCA") relating to the
manufacture of ALKS 3831 at the company's Wilmington, OH facility. Subsequent to
Alkermes' resubmission of the NDA, the FDA issued a new request for
records under Section 704(a)(4) of the FDCA to supplement the
information previously provided by the company. Neither the CRL nor
this subsequent records request identified or raised any concerns
about the clinical or non-clinical data in the NDA and the FDA has
not asked Alkermes to complete any new clinical trials to support
approval of the application.
Alkermes will continue to work closely with the FDA as it
completes its review of the ALKS 3831 NDA and remains committed to
making ALKS 3831 available to patients as quickly as possible.
About Schizophrenia
Schizophrenia is a serious brain disorder marked by positive
symptoms (hallucinations and delusions, disorganized speech and
thoughts, and agitated or repeated movements) and negative symptoms
(depression, blunted emotions and social
withdrawal).1 An estimated 2.4 million American
adults have schizophrenia,2 with men and women
affected equally.
About Bipolar I Disorder
Bipolar disorder is a brain disorder that causes shifts in a
person's mood, energy and ability to function. Individuals with
this brain disorder may experience debilitating mood shifts from
extreme highs (mania) to extreme lows (depression). Bipolar I
disorder is characterized by the occurrence of at least one manic
episode, with or without the occurrence of a major depressive
episode, and affects approximately one percent of the adult
population in the United States in any given
year.3
About ALKS 3831 (olanzapine/samidorphan)
ALKS 3831 is an investigational, novel, once-daily, oral atypical
antipsychotic drug candidate for the treatment of adults with
schizophrenia and for the treatment of adults with bipolar I
disorder. ALKS 3831 is composed of samidorphan, a novel, new
molecular entity, co-formulated with the established antipsychotic
agent, olanzapine, in a single bilayer tablet.
About Alkermes plc
Alkermes plc is a fully
integrated, global biopharmaceutical company developing innovative
medicines in the fields of neuroscience and oncology. The company
has a portfolio of proprietary commercial products focused on
addiction and schizophrenia, and a pipeline of product candidates
in development for schizophrenia, bipolar I disorder,
neurodegenerative disorders and cancer. Headquartered
in Dublin, Ireland, Alkermes plc has an R&D
center in Waltham, Massachusetts; a research and
manufacturing facility in Athlone, Ireland; and a
manufacturing facility in Wilmington, Ohio. For more information, please visit
Alkermes' website at www.alkermes.com.
Note Regarding Forward-Looking Statements
Certain
statements set forth in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including,
but not limited to, statements concerning: the potential
therapeutic and commercial value of ALKS 3831 for the treatment of
adults with schizophrenia and the treatment of adults with bipolar
I disorder; the company's expectations regarding next steps for the
NDA for ALKS 3831, including the FDA's PDUFA target action date for
the NDA and the company's plans to work with the FDA as it
completes its review of the NDA; and the company's commitment to
making ALKS 3831 available to patients as quickly as possible. The
company cautions that forward-looking statements are inherently
uncertain. Although the company believes that such statements are
based on reasonable assumptions within the bounds of its knowledge
of its business and operations, the forward-looking statements are
neither promises nor guarantees and they are necessarily subject to
a high degree of uncertainty and risk. Actual performance and
results may differ materially from those expressed or implied in
the forward-looking statements due to various risks and
uncertainties. These risks and uncertainties include, among others:
whether data from the company's manufacturing processes may be
interpreted by the FDA in different ways than the company
interprets it; potential changes in the cost, scope and duration of
the ALKS 3831 development and regulatory program following receipt
of the FDA's CRL and subsequent records request; whether the FDA
will approve the NDA for ALKS 3831 in a timely manner or at all; if
approved, whether the FDA will impose conditions on the marketing
of ALKS 3831, such as a risk evaluation and mitigation strategy;
whether future clinical trials for ALKS 3831, if any, will be
completed on time or at all; unanticipated impacts of the COVID-19
pandemic on the operations of the company and on the operations of
the regulatory agencies involved in the review and potential
approval of ALKS 3831; whether ALKS 3831 could be shown ineffective
or unsafe during clinical studies; and those risks and
uncertainties described under the heading "Risk Factors" in the
company's Annual Report on Form 10-K for the year ended Dec.
31, 2019, the company's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2020 and in subsequent filings
made by the company with the U.S. Securities and Exchange
Commission ("SEC"), which are available on
the SEC's website at www.sec.gov. Existing and
prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. Except as required by law, the company disclaims any
intention or responsibility for updating or revising any
forward-looking statements contained in this press release.
1American Psychiatric Association. Schizophrenia
Spectrum and Other Psychiatric Disorders. Diagnostic and
Statistical Manual of Mental
Disorders. 5th ed. Washington,
DC: American Psychiatric Publishing; 2013.
2 National Institutes of
Health. Schizophrenia. Accessed on Dec. 28,
2020 from
https://archives.nih.gov/asites/report/09-09-2019/report.nih.gov/nihfactsheets/Pdfs/Schizophrenia(NIMH).pdf.
3 Merikangas et al. Lifetime and 12-Month
Prevalence of Bipolar Spectrum Disorder in the National Comorbidity
Survey Replication. Arch Gen Psychiatry, 2007 May;
64(5): 543-552.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1931566/
Alkermes Contacts:
For
Investors:
|
Sandy
Coombs
|
+1 781 609
6377
|
For Media:
|
Marisa
Borgasano
|
+1 781 609
6659
|
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