The FDA has issued a Complete Response Letter (CRL) to AbbVie for its Parkinson’s treatment ABBV-951 due to issues with a third-party manufacturer. The regulator did not highlight safety or efficacy concerns with the drug or its administration device. Although this is the second setback to AbbVie’s U.S. approval efforts, following a previous CRL in March 2023 regarding the infusion pump, AbbVie says it remains focused on addressing the FDA's concerns to successfully bring the therapy to market.

AbbVie (NYSE: ABBV) today 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.

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