NORTH
CHICAGO, Ill., March 22,
2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced it received a Complete Response Letter (CRL) from the
U.S. Food and Drug Administration (FDA) for the New Drug
Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the
treatment of motor fluctuations in adults with advanced Parkinson's
disease.
In its letter, the FDA requested additional information about
the device (pump) as part of the NDA review. The CRL does not
request that AbbVie conduct additional efficacy and safety trials
related to the drug. AbbVie plans to resubmit the NDA as soon as
possible.
"There is an unmet need for people living with advanced
Parkinson's disease as they face daily challenges in managing their
condition," said Thomas Hudson,
M.D., senior vice president, research and development, chief
scientific officer, AbbVie. "We will continue to work closely with
the FDA as part of our commitment to bringing this treatment option
to people impacted by this disease as quickly as possible."
The NDA submission is based on results from a Phase 3,
head-to-head, randomized and controlled clinical trial
demonstrating statistically significant improvement in "On" time
without troublesome dyskinesia compared to oral immediate-release
carbidopa/levodopa (CD/LD).1
About ABBV-951
ABBV-951 (foscarbidopa/foslevodopa) is
a solution of carbidopa and levodopa prodrugs for continuous
subcutaneous delivery that is being investigated for the treatment
of motor fluctuations in patients with advanced Parkinson's
disease.
About AbbVie in Neuroscience
At AbbVie, our commitment
to preserve the personhood of those living with neurological and
psychiatric disorders is unwavering. Every challenge in this
uncharted territory makes us more determined and drives us harder
to discover and deliver solutions for patients, care partners and
clinicians. AbbVie's Neuroscience portfolio consists of approved
therapies in neurological and psychiatric disorders, including
bipolar I disorder, major depressive disorder, migraine,
Parkinson's disease, post-stroke spasticity, schizophrenia, and
others along with a robust pipeline.
We have a strong investment in neuroscience research, with our
Foundational Neuroscience Center in Cambridge, Massachusetts, and our Neuroscience
Discovery site in Ludwigshafen, Germany, where our research and resilience in
these challenging therapeutic areas is yielding a deeper
understanding of the pathophysiology of neurological and
psychiatric disorders and identifying targets for potential
disease-modifying therapeutics aimed at making a difference in
people's lives.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across our
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com.
Follow @AbbVie on Twitter, Facebook, Instagram,
YouTube, and LinkedIn
Forward-Looking Statements
Some statements in this
news release are, or may be considered, forward-looking statements
for purposes of the Private Securities Litigation Reform Act of
1995. The words "believe," "expect," "anticipate," "project" and
similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, failure to realize
the expected benefits from AbbVie's acquisition of Allergan plc
("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2021 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
References:
1 AbbVie (October 28, 2021). AbbVie Announces ABBV-951
(Foslevodopa/Foscarbidopa) Showed Improvement in Controlling Motor
Fluctuations Compared to Oral Levodopa/Carbidopa Medication in
Pivotal Phase 3 Trial in Patients with Advanced Parkinson's
Disease [Press release].
https://news.abbvie.com/news/press-releases/abbvie-announces-abbv-951-foslevodopafoscarbidopa-showed-improvement-in-controlling-motor-fluctuations-compared-to-oral-levodopacarbidopa-medication-in-pivotal-phase-3-trial-in-patients-with-advanced-parkinsons-disease.htm
US-NEUP-230012
View original
content:https://www.prnewswire.com/news-releases/abbvie-provides-regulatory-update-on-abbv-951-foscarbidopafoslevodopa-new-drug-application-301777945.html
SOURCE AbbVie