FDA asks AbbVie for more information on Parkinson’s treatment pump
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The FDA has issued a complete response letter to AbbVie regarding its new drug application for ABBV-951 for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
According to a press release from AbbVie, the FDA, in its NDA review, requested additional information about the pump used for the subcutaneous delivery of ABBV-951 (foscarbidopa/foslevodopa), which is a solution of carbidopa and levodopa prodrugs. However, the letter does not request additional safety and efficacy trials related to the drug.
The NDA submission, made in May 2022, was based on results from a phase 3, head-to-head, randomized controlled clinical trial that enrolled nearly 130 adults with PD whose symptoms were no longer controlled by medication. Per the release, the combination therapy demonstrated statistically significant improvement in “on” time without troublesome dyskinesia compared with oral, immediate-release carbidopa/levodopa.
“There is an unmet need for people living with advanced Parkinson’s disease as they face daily challenges in managing their condition,” Thomas Hudson, MD, senior vice president of research and development and chief scientific officer at AbbVie, stated in the 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 company plans to resubmit the NDA as soon as possible.