AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa)
AbbVie announced it received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for ABBV-951, a treatment for motor fluctuations in advanced Parkinson's disease. The CRL is due to observations from an inspection at a third-party manufacturing facility not involving ABBV-951. Importantly, the CRL does not cite any safety, efficacy, or labeling issues related to ABBV-951, nor does it request additional efficacy or safety trials. AbbVie continues to work with the FDA to expedite bringing ABBV-951 to U.S. patients.
- None.
- FDA issued a Complete Response Letter (CRL) for ABBV-951.
- Inspection issues at a third-party manufacturing facility necessitated the CRL.
Insights
The FDA's issuance of a Complete Response Letter (CRL) for ABBV-951, a treatment for motor fluctuations in advanced Parkinson's disease, holds intricate implications. While the CRL does not challenge the safety or efficacy of the drug, its basis on observations at a third-party manufacturer raises concerns. Such regulatory setbacks can delay market entry, impacting patient access to potentially beneficial treatments. Importantly, the CRL does not mandate additional clinical trials, suggesting AbbVie's data on ABBV-951 is robust. Nonetheless, frequent CRLs can tarnish a company's reputation, potentially influencing investor sentiment and stock performance. In the short term, this news might temper investor expectations; however, the absence of safety or efficacy concerns bodes well for ABBV-951's eventual approval.
From a financial perspective, the CRL could create a short-term overhang on AbbVie's stock price. Investors might react cautiously, given regulatory hurdles often imply unforeseen delays and associated costs. However, the absence of additional efficacy or safety trial requirements mitigates substantial financial risk and preserves the investment made in the clinical development of ABBV-951. In the long term, if AbbVie swiftly addresses the FDA’s observations, the drug's approval could still proceed without significant impact on the financial outlook. Long-term investors might view this as a buying opportunity if the stock dips on this news, given the drug’s potential in addressing unmet needs in Parkinson's disease treatment.
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
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 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
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