AbbVie reports that it received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its new drug application (NDA) for ABBV-951 (foscarbidopa /foslevodopa), a combination drug for treating motor fluctuations in adults with advanced Parkinson’s disease, due to manufacturing issues.  

In its CRL, the FDA cited observations that were identified during inspection of a third-party manufacturer listed in the NDA. AbbVie reported that the inspection at the facility did not involve ABBV-951 or any AbbVie medicine. 

AbbVie reported that 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. 

The company had estimated potential peak sales of more than $1 billion for ABBV-951, according to long-term guidance made by the company earlier this year (February 2024). ABBV-951 (foscarbidopa/foslevodopa) is a combination of carbidopa and levodopa prodrugs for 24-hour continuous subcutaneous administration via a pump. The 24-hour, continuous subcutaneous delivery was designed to improve “on” time for patients with Parkinson’s disease without dyskinesia (involuntary movements associated with certain central nervous systems drugs) compared to oral immediate-release carbidopa/levodopa products. ABBV-951 is positioned as a successor to the company’s Duopa (carbidopa and levodopa), which was approved in 2015 using a small, portable infusion pump that delivers carbidopa and levodopa directly into the small intestine for 16 continuous hours via a procedurally placed tube. ABBV-951 has been approved in 34 countries, including the European Union, where it was approved in November 2023 and launched in January 2024 as Produodopa. The drug is under review in the US for marketing approval.  

This is the second CRL that AbbVie has received for ABBV-951. The company initially filed for FDA approval of ABBV-951 in May 2022, but FDA issued a CRL in March 2023, seeking additional information on the pump.  

AbbVie says it continues to work with the FDA to bring ABBV-951 to the US market as quickly as possible. 

Source: AbbVie