AbbVie Hits Infusion Pump Snag for Parkinson’s Disease Candidate

The FDA said it could not approve AbbVie’s new drug application (NDA) for ABBV-951 (foslevodopa/foscarbidopa), an investigational therapy for advanced Parkinson’s disease, because of concerns about the delivery device.

In a Complete Response Letter to the company, the agency asked for additional information about the infusion pump, which delivers the drug solution subcutaneously.

The FDA did not call for more efficacy and safety trials related to the combination therapy, the company said.

AbbVie said it will continue to work closely with the FDA on the issue and resubmit the NDA as soon as possible.