The U.S. FDA has handed AbbVie a second complete response letter for its blockbuster-hopeful treatment of motor fluctuations in advanced Parkinson's disease, this time citing inspection issues at a third-party manufacturing facility.
According to an AbbVie press release, the CRL noted observations that were identified during inspection of a third-party manufacturer listed in AbbVie's NDA for foscarbidopa/foslevodopa (ABBV-951). The inspection at the facility did not involve the continuous infusion therapy candidate or any AbbVie medicine.
Importantly, the CRL did not identify any issues related to the safety, efficacy or labeling of ABBV-951, including the device — which was the issue last March, when the agency issued its first rejection, requesting additional information about the device (pump) as part of the NDA review.
ABBV-951 is a solution of carbidopa and levodopa prodrugs for subcutaneous delivery, administered continuously under the skin using a pump. AbbVie is counting on ABBV-951 to reach $1 billion peak annual sales, capturing approximately 12% of the global Parkinson's disease market.
The NDA submissions were based on results from a phase 3, head-to-head, randomized and controlled clinical trial demonstrating statistically significant improvement in "on" state time without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa.
AbbVie says it will continue to work with the FDA to bring ABBV-951 to patients.
