AbbVie Provides Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa) New Drug Application

Rhea-AI Summary

AbbVie (NYSE: ABBV) announced on March 22, 2023, that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for ABBV-951 (foscarbidopa/foslevodopa) aimed at treating motor fluctuations in adults with advanced Parkinson's disease. The FDA's letter requests additional information about the delivery device but does not require further efficacy or safety trials for the drug. AbbVie plans to resubmit the NDA promptly. The application was based on a successful Phase 3 clinical trial showing significant improvement in patient outcomes compared to existing oral treatments.

Positive

• Successful Phase 3 trial showing significant improvement in motor control for advanced Parkinson's patients.
• AbbVie plans to quickly resubmit the NDA, indicating commitment to bringing the drug to market.

Negative

• Complete Response Letter indicates regulatory delays.
• Request for additional device information may prolong the approval process.

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.

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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

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SOURCE AbbVie

FAQ

What is ABBV-951 and how does it treat Parkinson's disease?

ABBV-951 (foscarbidopa/foslevodopa) is a drug being investigated for the treatment of motor fluctuations in adults with advanced Parkinson's disease, designed for continuous subcutaneous delivery.

What did the FDA request in the Complete Response Letter for ABBV-951?

The FDA requested additional information about the delivery device used in the New Drug Application but did not ask for further trials regarding the drug's efficacy or safety.

What are the implications of the Complete Response Letter for ABBV-951?

The Complete Response Letter indicates regulatory delays and requires additional information, potentially affecting the timeline for market availability.

When does AbbVie plan to resubmit the NDA for ABBV-951?

AbbVie plans to resubmit the NDA for ABBV-951 as soon as possible following the FDA's feedback.