AbbVie’s Parkinson’s Disease Therapy Rejected by FDA Due to Third-Party Manufacturer Issues

1. FDA Rejection: The U.S. Food and Drug Administration (FDA) has rejected AbbVie's New Drug Application (NDA) for ABBV-951, a therapy for motor fluctuations in adults with advanced Parkinson's disease, citing issues at a third-party manufacturer.
2. Third-Party Issues: The FDA's Complete Response Letter (CRL) flagged observations during an inspection of a third-party manufacturer listed in the NDA, although the inspection did not involve ABBV-951 or any AbbVie medicine.
3. No Safety or Efficacy Concerns: The CRL did not identify any issues related to the safety, efficacy, or labeling of ABBV-951, including the device.
4. No Additional Trials Required: AbbVie is not required to conduct additional efficacy and safety trials related to the drug or device-related testing.
5. Global Progress: ABBV-951 has been approved in 34 countries, and over 2,100 patients worldwide have started treatment. AbbVie continues to work with regulatory authorities to bring the therapy to people living with advanced Parkinson's disease.
6. Competitor Rejection: Mitsubishi Tanabe Pharma's ND-0612, a similar continuous subcutaneous infusion therapy, was also hit with a CRL earlier this month.
7. Industry Challenges: Infusion pump-based therapies have posed problems for other drugmakers developing Parkinson's disease drugs, such as Supernus, which received a third rejection of its prospect SPN-830.