In a complete response letter, the FDA has requested information about the pump that will be used to deliver ABBV-951, which will provide continuous subcutaneous delivery of oral immediate-release carbidopa/levodopa.
The FDA has issued a complete response letter (CRL) for AbbVie’s new drug application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) to treat adults with Parkinson’s disease with motor fluctuations. Parkinson’s disease, a progressive and chronic neurological disorder resulting from the loss of dopamine-producing brain cells, which primarily manifests with tremor, muscle rigidity, slowness of movement and difficulty with balance.
ABBV-951 is a combination of foscarbidopa and foslevodopa, which are prodrugs of carbidopa and levodopa, which are common therapies used in the treatment of Parkinson’s disease. The new therapy is designed to provide 24-hour, continuous subcutaneous delivery of oral immediate-release carbidopa/levodopa.
In its letter, the FDA requested additional information about the device (pump) as part of the NDA review. The CRL does not request that AbbVie conduct additional efficacy and safety trials related to the drug.
“There is an unmet need for people living with advanced Parkinson's disease as they face daily challenges in managing their condition,” Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie, said in a press release. “We will continue to work closely with the FDA as part of our commitment to bringing this treatment option to people impacted by this disease as quickly as possible.”
The NDA submission is based on results from a phase 3, head-to-head trial demonstrating statistically significant improvement in “on” time without dyskinesia (involuntary movements of face, arms and legs) compared with oral immediate-release carbidopa/levodopa.
The majority of the adverse events reported were non-serious and mild-to-moderate in severity in the ABBV-951 group, but incidence of hallucination and psychosis adverse events was higher in the ABBV-951 group than in the oral carbidopa/levodopa group. Incidence of serious adverse events were 8% in the ABBV-951 group and 6% in oral carbidopa/levodopa group. There was one patient with a treatment-emergent adverse event that led to death in the oral carbidopa/levodopa group and none in the ABBV-951 group.