FDA again rejects AbbVie's Parkinson's combo

The U.S. FDA has issued a second complete response letter (CRL) to AbbVie for its promising treatment targeting motor fluctuations in advanced Parkinson's disease. The latest CRL points to inspection issues at a third-party manufacturing facility.

AbbVie announced in a press release that the observations noted in the CRL were found during an inspection of a third-party manufacturer included in AbbVie's New Drug Application (NDA) for foscarbidopa/foslevodopa (ABBV-951). It is important to note that the inspection did not concern the continuous infusion therapy candidate or any other medication produced by AbbVie.

Crucially, the CRL did not raise concerns regarding the safety, efficacy, or labeling of ABBV-951, including its device component. This marks a change from last March when the FDA issued its first rejection, citing the need for additional information about the device (pump) used for administration as part of the NDA review process.

ABBV-951 is a subcutaneous solution of carbidopa and levodopa prodrugs, delivered continuously via a pump. AbbVie is banking on ABBV-951 to reach peak annual sales of $1 billion, capturing about 12% of the global Parkinson's disease market.

The NDA submissions were supported by data from a phase 3 clinical trial. This head-to-head, randomized, and controlled study demonstrated statistically significant improvements in "on" state time without troublesome dyskinesia when compared to oral immediate-release carbidopa/levodopa.

Despite this setback, AbbVie stated it will continue to collaborate with the FDA to bring ABBV-951 to patients in need.