AbbVie’s Duopa Successor in Parkinson’s Rejected Again Due to Third-Party Manufacturer Issues

1. FDA Rejection: The U.S. Food and Drug Administration (FDA) has rejected AbbVie's ABBV-951, a successor to Duopa, for the treatment of Parkinson's disease due to issues at a third-party manufacturer.
2. Reason for Rejection: The FDA's complete response letter cited observations from the inspection of the third-party manufacturer, leading to the denial of the marketing application in its current state.
3. No Safety or Efficacy Concerns: The FDA did not raise any concerns about the safety, efficacy, or labeling of ABBV-951, nor did it request further trials.
4. Previous Rejection: This is the second rejection for ABBV-951, with the first rejection occurring due to the need for additional information about the delivery device.
5. Potential Sales: Analysts predict potential sales of $619.67 million for ABBV-951 by 2026.
6. Collaboration with FDA: AbbVie is working with the FDA to address the issues and make the therapy available to U.S. patients.
7. Competitor: Mitsubishi Tanabe Pharma's ND-0612, another continuous subcutaneous infusion therapy, also faced a CRL earlier this month.