AbbVie Hits 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.
The NDA was supported by results from a late-stage study with 130 participants, in which patients who received ABBV-951 saw meaningful improvements in their “on” time without uncontrolled muscle movements.
AbbVie said it will continue to work closely with the FDA on the issue and resubmit the NDA as soon as possible.
March 27, 2023