AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa)

AbbVie announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.

In its letter, the FDA cited observations that were identified during inspection of a third-party manufacturer listed in the New Drug Application (NDA). The inspection at the facility did not involve ABBV-951 or any AbbVie medicine.

“There remains a tremendous unmet need for treatment options for patients living with advanced Parkinson’s disease in the United States,” said Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, AbbVie. “We are focused on working with the FDA to bring this important therapy to patients as soon as possible.”

The CRL does not identify any issues related to the safety, efficacy or labeling of ABBV-951, including the device. The CRL does not request that AbbVie conduct additional efficacy and safety trials related to the drug or device-related testing.