AbbVie Delivers Breakthrough News on Foscarbidopa/Foslevodopa: Regulators Take Notice!

AbbVie has been dealt a major setback in its efforts to bring a novel treatment for motor fluctuations in adults with advanced Parkinson’s disease to market, following the receipt of 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). Despite the setback, AbbVie remains committed to finding a viable treatment and will continue to explore potential solutions.

The FDA has requested additional information about AbbVie’s device (pump), prompting the company to resubmit its NDA without conducting any additional efficacy and safety trials. AbbVie is committed to providing the necessary information as soon as possible to ensure a speedy review process.

At AbbVie, we understand the daily struggles faced by those living with advanced Parkinson’s disease. That’s why we are committed to bringing a new treatment option to those affected as quickly as possible.

We are continuing to work closely with the FDA to make this possible, and are determined to help meet the unmet needs of people in this situation. Thomas Hudson, M.D., Senior Vice President, Research and Development and Chief Scientific Officer, states, “We are dedicated to bringing this treatment option to those impacted by this disease.”

The results from a Phase 3, randomized and controlled clinical trial have been submitted to the NDA, showing a statistically significant improvement in “On” time without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa (CD/LD). This groundbreaking head-to-head study is paving the way for new treatments and hope for those living with Parkinson’s disease.

About ABBV-951

ABBV-951 (foscarbidopa/foslevodopa) is a revolutionary solution for continuous subcutaneous delivery of carbidopa and levodopa prodrugs that could revolutionize the treatment of motor fluctuations in patients with advanced Parkinson’s disease. This cutting-edge treatment has the potential to improve the quality of life of those living with this debilitating condition.

About AbbVie in Neuroscience

At AbbVie, we are committed to ensuring the personhood of those living with neurological and psychiatric disorders. Our Neuroscience portfolio includes approved therapies in multiple disorders, including bipolar I disorder, major depressive disorder, migraine, Parkinson’s disease, post-stroke spasticity, schizophrenia, and more.

We are also actively working to develop a robust pipeline of innovative solutions to address the unique challenges of these conditions. Our dedication to providing treatments that make a meaningful difference in patients’ lives drives us to explore further and push boundaries, so that we can deliver meaningful solutions.

At our Foundational Neuroscience Center in Cambridge, Massachusetts, and our Neuroscience Discovery site in Ludwigshafen, Germany, we are investing in neuroscience research in a major way.

Our research and resilience in these difficult therapeutic areas is enabling us to gain a deeper insight into the pathophysiology of neurological and psychiatric disorders, and to identify potential targets for disease-modifying treatments that could make a real difference in people’s lives.

About AbbVie

At AbbVie, we are committed to revolutionizing healthcare. Our mission is to develop and deliver groundbreaking medicines that combat serious health issues and tackle the medical challenges of tomorrow.

We make a meaningful difference in people’s lives, focusing our efforts on key therapeutic areas such as immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, as well as products and services from our Allergan Aesthetics portfolio. We are dedicated to finding solutions that improve quality of life and bring hope to those who need it most.

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