AbbVie Updates U.S. Regulatory Status of ABBV-951

AbbVie, headquartered in North Chicago, Illinois, announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa), a treatment for motor fluctuations in adults with advanced Parkinson's disease. The CRL was issued due to observations made during an inspection of a third-party manufacturing facility mentioned in the NDA. Importantly, this inspection and its findings were unrelated to ABBV-951 or any other AbbVie medicine.

Roopal Thakkar, M.D., senior vice president and chief medical officer for global therapeutics at AbbVie, emphasized the significant unmet need for advanced Parkinson's disease treatments in the U.S. and reaffirmed the company's commitment to collaborating with the FDA to make ABBV-951 available to patients as swiftly as possible.

The CRL from the FDA did not highlight any concerns regarding the safety, efficacy, or labeling of ABBV-951, including its device. Furthermore, the letter did not require AbbVie to conduct additional efficacy or safety trials related to the drug or its associated device.

ABBV-951 is a solution combining prodrugs of carbidopa and levodopa intended for continuous 24-hour subcutaneous infusion, designed to manage motor fluctuations in adults with advanced Parkinson's disease. This treatment has already received approval in 34 countries, and over 2,100 patients worldwide have commenced treatment. AbbVie is actively working with regulatory bodies globally to extend the availability of ABBV-951 to more patients with advanced Parkinson's disease.

AbbVie is dedicated to discovering and delivering innovative medicines and solutions to address significant health challenges today and in the future. The company aims to make a substantial impact on patients' lives across various key therapeutic areas, including immunology, oncology, neuroscience, and eye care. AbbVie's portfolio also includes products and services in Allergan Aesthetics.