AbbVie’s (NYSE:ABBV) new drug application for its Parkinson’s disease combination therapy has been denied approval by the FDA.
In a complete response letter sent to the drugmaker, the U.S. drug regulator cited observations that were identified during inspection of a third-party manufacturer listed in the application. The inspection at the facility did not involve ABBV-951 or any AbbVie medicine.
The FDA did not raise any issues related to the safety, efficacy or labeling of the drug, and does not require the company to conduct additional trials related to the drug.
“We are focused on working with the FDA to bring this important therapy to patients as soon as possible,” the pharma giant said in a statement.
Approved in 34 countries, ABBV-951 (foscarbidopa/foslevodopa) is a solution of carbidopa and levodopa prodrugs for 24-hour continuous subcutaneous infusion for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
Last year, AbbVie’s (ABBV) hit a snag with its regulatory efforts when the FDA rejected application for ABBV-951, requesting additional information about the subcutaneous pump device as part of the review. The FDA had not raised any questions about ABBV-951’s efficacy or safety at that time as well.