The U.S. FDA has handed AbbVie a complete response letter for the drugmaker's blockbuster-hopeful treatment of motor fluctuations in adults with advanced Parkinson's disease.
In its letter, the FDA requested additional information about the device (pump) as part of the NDA review.
ABBV-951 (foscarbidopa/foslevodopa) is a solution of carbidopa and levodopa prodrugs for continuous subcutaneous delivery that is being investigated for the treatment of motor fluctuations in patients with advanced Parkinson's disease. The solution is administered continuously under the skin using a pump.
AbbVie's NDA submission was 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 was counting on ABBV-951 to reach $1 billion peak annual sales, capturing approximately 12% of the global Parkinson's disease market.
The CRL did not request that AbbVie conduct additional efficacy and safety trials related to the drug. AbbVie says it plans to resubmit the NDA as soon as possible.
