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FDA Rejects Parkinson Drug Due to 3rd-Party Manufacturing Concerns
The US Food and Drug Administration (FDA) rejected AbbVie’s ABBV-95 (foscarbidopa/foslevodopa) last week, raising concerns via complete response letter (CRL) regarding the inspection of a third-party manufacturer listed in the drug application.
AbbVie clarified that the CRL did not “identify any issues related to the safety, efficacy, or labeling of ABBV-951” and that the FDA had not requested that further drug trials be conducted.
The rejection of ABBV-95 is its second in just over a year. In March 2023, the FDA declined approval and requested additional information about the drug’s delivery device.
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The drug manufacturer’s prospective therapy is a combination of foscarbidopa and foslevodopa, the respective prodrugs for carbidopa and levodopa which are included in Duopa, another AbbVie Parkinson disease drug that was approved in 2015. ABBV-951 is a 24-hour continuous subcutaneous infusion, which some neurologists have described as a “less invasive and cumbersome option” than the existing Duopa.
Despite setbacks in the US market, ABBV-951 has been approved in 34 countries, with an estimated 2100 patients having already initiated treatment.
"There remains a tremendous unmet need for treatment options for patients living with advanced Parkinson disease in the United States," said Roopal Thakkar, MD, 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."
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