The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug application (NDA) of AbbVie’s ABBV-951 (foscarbidopa/foslevodopa) to treat motor fluctuations in adult patients with advanced Parkinson’s disease.
The CRL was issued based on findings from an inspection that did not involve ABBV-951 or any medicine of the company.
The US regulator highlighted findings made during an examination of a third-party manufacturer mentioned in the NDA.
AbbVie global therapeutics senior vice-president and chief medical officer Roopal Thakkar stated: “There remains a tremendous unmet need for treatment options for patients living with advanced Parkinson’s disease in the US.
“We are focused on working with the FDA to bring this important therapy to patients as soon as possible.”
The CRL found no problems with the efficacy, safety or labelling of ABBV-951, including the device.
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It does not require AbbVie to conduct any additional safety or efficacy trials for the medicine or device.
AbbVie is continuing its talks with the FDA to make ABBV-951 available for patients in the US as soon as possible.
ABBV-951 contains carbidopa and levodopa prodrugs for 24-hour continuous subcutaneous delivery to treat motor fluctuations in individuals with advanced Parkinson’s disease.
It has been approved in 34 countries, and more than 2,100 patients have begun treatment.
AbbVie is collaborating with regulatory agencies internationally to offer ABBV-951 to those with the disease.
The company recently announced FDA approval for SKYRIZI (risankizumab-rzaa) to treat adult patients with moderately to severely active ulcerative colitis.
SKYRIZI is the first IL-23 inhibitor to receive approval for moderate to severe ulcerative colitis and Crohn’s disease indications, broadening its therapeutic reach in inflammatory bowel disease.
