AbbVie said on Tuesday the US Food and Drug Administration had declined to approve its therapy to treat motor fluctuations in Parkinson's disease patients, citing manufacturing concerns at a third-party manufacturer.
The inspection at the facility did not involve the Parkinson's therapy called ABBV-951 or any other AbbVie medicine.
The letter also did not identify any issues related to the safety, efficacy or labeling of the therapy, including the device, and did not request that AbbVie conduct additional efficacy and safety trials.
The therapy, ABBV-951, is a formulation of carbidopa-levodopa, the standard of care for the disease. It is administered subcutaneously, or under the skin, through an infusion pump.
Published 25 June 2024, 13:16 IST