The US Food and Drug Administration (FDA) has rejected AbbVie’s Parkinson’s disease therapy, ABBV-951 (foscarbidopa/foslevodopa), for the second time due to issues at a third-party manufacturer.
The regulator’s decision was conveyed to the company via a complete response letter (CRL) for the new drug application (NDA) for ABBV-951.
In its letter, the FDA referred to findings noted during an inspection of a third-party manufacturer listed in the NDA.
The assessment of the facility did not involve ABBV-951 or any other medicines manufactured by AbbVie.
The CRL does not raise any concerns regarding the safety, efficacy, or labelling of the Parkinson’s drug candidate, including the device.
Furthermore, the letter does not require AbbVie to undertake additional efficacy and safety trials related to the drug or device-related testing.
ABBV-951 is approved in 34 countries as a 24-hour continuous subcutaneous infusion to treat motor fluctuations in adults with advanced Parkinson’s disease.
It is a combination of carbidopa-levodopa, the standard of care for the disease. The drug is administered via an infusion pump to improve patients’ motor functions.
In March 2023, the FDA rejected the NDA of ABBV-951 and asked for more information on the device used to administer the therapy.
The American pharmaceutical company stated that it remains committed to collaborating with the FDA to make the therapy available to US patients.
AbbVie global therapeutics chief medical officer and senior vice president Roopal Thakkar said: “There remains a tremendous unmet need for treatment options for patients living with advanced Parkinson’s disease in the United States.
“We are focused on working with the FDA to bring this important therapy to patients as soon as possible.”
