- U.S. Food and Drug Administration (FDA) issues Complete
Response Letter (CRL) for ABBV-951 based on observations from an
inspection that did not involve ABBV-951 at one of AbbVie's
third-party manufacturing facilities
- The CRL does not identify any issues related to the safety,
efficacy or labeling of ABBV-951, including the device, and does
not request that AbbVie conduct additional efficacy or safety
trials related to the drug or device-related testing
- AbbVie continues to work with the FDA to bring ABBV-951 to
patients in the U.S. as quickly as possible
NORTH
CHICAGO, Ill., June 25,
2024 /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 cited observations that were identified
during inspection of a third-party manufacturer listed in the New
Drug Application (NDA). The inspection at the facility did not
involve ABBV-951 or any AbbVie medicine.
"There remains a tremendous unmet need for treatment options for
patients living with advanced Parkinson's disease in the United States," said Roopal Thakkar, M.D., senior vice president,
chief medical officer, global therapeutics, AbbVie. "We are focused
on working with the FDA to bring this important therapy to patients
as soon as possible."
The CRL does not identify any issues related to the safety,
efficacy or labeling of ABBV-951, including the device. The CRL
does not request that AbbVie conduct additional efficacy and safety
trials related to the drug or device-related testing.
About ABBV-951
ABBV-951
(foscarbidopa/foslevodopa) is a solution of carbidopa and
levodopa prodrugs for 24-hour continuous subcutaneous infusion for
the treatment of motor fluctuations in adults with advanced
Parkinson's disease. ABBV-951 has been approved in 34 countries and
over 2,100 patients worldwide have started treatment. AbbVie
continues to work with regulatory authorities around the world to
bring ABBV-951 to people living with advanced Parkinson's
disease.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
and solutions 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, and eye care – and products and
services in our Allergan Aesthetics portfolio. For more information
about AbbVie, please visit us at www.abbvie.com. Follow @abbvie
on LinkedIn, Facebook, Instagram, X (formerly Twitter), and
YouTube.
AbbVie 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 and uses of future
or conditional verbs, 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 expressed or implied in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry. 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 2023 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, and specifically declines, to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
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SOURCE AbbVie