Alkermes Provides Update on FDA Review of ARISTADA™ for the Treatment of Schizophrenia
August 21 2015 - 4:00PM
Business Wire
Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food
and Drug Administration (FDA) has advised Alkermes that it will not
be able to complete its review of the New Drug Application (NDA)
for ARISTADA™ (aripiprazole lauroxil) for the treatment of
schizophrenia by the Prescription Drug User Fee Act (PDUFA) action
date of Aug. 22, 2015. The FDA indicated that this delay was
expected to be brief, measured in terms of weeks, but could not
confirm specific timing. The FDA also indicated that no additional
data or information is required from Alkermes at this time.
“We are confident in the ARISTADA program and our NDA
submission, and we will work closely with the FDA as they complete
their review,” said Elliot Ehrich, M.D., Chief Medical Officer of
Alkermes. “We look forward to bringing ARISTADA to market as a
potential new treatment option to help address the significant
unmet medical needs of patients living with schizophrenia.”
About ARISTADA™
ARISTADA is an injectable atypical antipsychotic with one-month
and extended-duration formulations in development for the treatment
of schizophrenia. Once in the body, ARISTADA converts to
aripiprazole. As a long-acting investigational medication based on
Alkermes’ proprietary LinkeRx® technology, ARISTADA is designed to
have multiple dosing options and to be administered in a
ready-to-use, pre-filled product format.
About Alkermes
Alkermes plc is a fully integrated, global biopharmaceutical
company developing innovative medicines for the treatment of
central nervous system (CNS) diseases. The company has a
diversified commercial product portfolio and a substantial clinical
pipeline of product candidates for chronic diseases that include
schizophrenia, depression, addiction and multiple sclerosis.
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 timing and outcome of
FDA regulatory review of the NDA submission for ARISTADA for the
treatment of schizophrenia and its potential therapeutic value, and
the commercial potential of ARISTADA. 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 ARISTADA will be
approved by regulatory authorities for the treatment of
schizophrenia; if approved, whether ARISTADA will be commercialized
successfully; whether ARISTADA could be shown ineffective or
unsafe; and those risks described in the Alkermes plc Quarterly
Report on Form 10-Q for the period ended June 30, 2015 and Annual
Report on Form 10-K for the fiscal year ended Dec. 31, 2014, and in
any other 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. The information contained in this
press release is provided by the company as of the date hereof,
and, except as required by law, the company disclaims any intention
or responsibility for updating or revising any forward-looking
information contained in this press release.
ARISTADA™ and LinkeRx® are trademarks of Alkermes Pharma Ireland
Limited.
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version on businesswire.com: http://www.businesswire.com/news/home/20150821005657/en/
Alkermes Contacts:For
Investors:Rebecca Peterson, +1 781-609-6378orFor Media:Jennifer
Snyder, +1 781-609-6166
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