AbbVie's Duopa successor for Parkinson's rejected again over FDA concerns with manufacturer

AbbVie has encountered another obstacle in its attempt to introduce a more user-friendly treatment for Parkinson’s disease. The U.S. Food and Drug Administration (FDA) has once again declined AbbVie’s application for ABBV-951, a medication intended to manage motor fluctuations in patients with advanced Parkinson’s disease.

The FDA’s rejection came in the form of a complete response letter, which highlighted issues discovered during an inspection of a third-party manufacturing facility mentioned in AbbVie’s drug application. Importantly, the inspection did not pertain to ABBV-951 or any other AbbVie medication, the company emphasized.

ABBV-951 is a combination of foscarbidopa and foslevodopa, which are prodrugs of carbidopa and levodopa, respectively. These are the active ingredients in Duopa, AbbVie’s Parkinson’s treatment approved in 2015. Prodrugs are inactive compounds that become active once they enter the body.

Despite the setback, AbbVie remains committed to collaborating with the FDA to advance ABBV-951. Dr. Roopal Thakkar, Senior Vice President and Chief Medical Officer of Global Therapeutics at AbbVie, stated the company’s dedication to moving forward with the medication.

Notably, the FDA’s letter did not cite any concerns regarding the safety, efficacy, or labeling of ABBV-951, including its subcutaneous pump device. The delivery device had previously posed challenges for AbbVie. Last March, the FDA rejected ABBV-951 due to the need for additional information about the device.

ABBV-951 is designed to offer a more convenient alternative to Duopa, a nearly decade-old medication that comes in a gel form and must be administered orally via a pump through a stomach tube. In contrast, ABBV-951 is delivered continuously under the skin using a pump.

AbbVie’s press release clarified that no additional efficacy or safety trials would be required for ABBV-951 or its delivery device. Previously, Wall Street analysts projected ABBV-951’s peak sales could reach $1 billion, with some suggesting it could potentially exceed $2 billion.

AbbVie’s new treatment could eventually face competition from Mitsubishi Tanabe Pharma’s ND-0612, another continuous subcutaneous infusion of liquid levodopa and carbidopa. Mitsubishi Tanabe acquired this treatment in its $1.1-billion purchase of NeuroDerm in 2017. However, ND-0612 also faced a setback recently, receiving a complete response letter earlier this month. The Japanese company indicated it would review the FDA’s comments and work to address the issues.

Other companies developing infusion pump-based therapies for Parkinson’s disease have also encountered challenges. For example, Supernus received a third rejection for its SPN-830 due to issues related to product quality and the drug’s infusion device. Despite the setbacks, Supernus remains committed to bringing SPN-830 to market and plans to work with the FDA to address the concerns.

In summary, despite the recent FDA rejection, AbbVie is determined to bring its new Parkinson’s disease treatment, ABBV-951, to market. The company plans to continue working with the regulatory agency to address the issues raised and advance the medication for patients with advanced Parkinson’s disease.