FDA Issues Second Complete Response Letter for AbbVie’s Parkinson’s Therapy


The FDA cited issues related to a third-party manufacturer. The agency did not request any additional testing from AbbVie.

The FDA has issued a complete response letter for AbbVie’s new drug application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) to treat 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. 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.

Parkinson’s disease, a progressive and chronic neurological disorder resulting from the loss of dopamine-producing brain cells, which primarily manifests with tremor, muscle rigidity, slowness of movement and difficulty with balance. About 500,000 Americans are diagnosed with Parkinson’s disease, according to the National Institute of Neurological Disorders and Stroke. This expected to double by 2040.

Roopal Thakkar, M.D.

Roopal Thakkar, M.D.

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

In May 2024, the U.S. Senate passed The National Plan to End Parkinson’s Act (H.R.2365/S.1064); the House had passed the bill in December 2023. The bill would create a federal advisory council to create and implement a national plan to better diagnose, prevent, treat and ultimately cure Parkinson’s disease.

ABBV-951 is a combination of foscarbidopa and foslevodopa, which are prodrugs of carbidopa and levodopa. These two drugs are common therapies used in the treatment of Parkinson’s disease. AbbVie’s product is designed to provide 24-hour, continuous subcutaneous delivery of oral immediate-release carbidopa/levodopa.

Related: FDA Wants More Information about AbbVie’s Parkinson’s Therapy

This is the second time the FDA has issued a complete response letter. In March 2023, the FDA requested information about the pump that will be used to deliver ABBV-951.

AbbVie launched the Parkinson’s therapy in Europe in January 2024 with the brand name ProDuodopa. It had been granted European approval in the third quarter of 2022.

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