AbbVie's ABBV-951 (Foscarbidopa/Foslevodopa) Receives Complete Response Letter from FDA
核心洞察
AbbVie (搜索) received a Complete Response Letter (CRL) from the FDA for its New Drug Application for ABBV-951 (foscarbidopa/foslevodopa).
The FDA's response cited observations from a third-party manufacturer inspection, unrelated to ABBV-951 or any AbbVie (搜索) medicine.
The CRL does not raise concerns regarding the safety, efficacy, or labeling of ABBV-951, including the delivery device.
AbbVie (搜索) has announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa). This drug is intended for the treatment of motor fluctuations in adult patients with advanced Parkinson's disease (搜索).
The FDA's CRL was based on observations made during an inspection of a third-party manufacturing facility listed in the NDA. It is important to note that the inspection did not involve ABBV-951 itself or any other AbbVie (搜索) product.
Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, AbbVie (搜索), stated, "There remains a tremendous unmet need for treatment options for patients living with advanced Parkinson's disease (搜索) in the United States. We are focused on working with the FDA to bring this important therapy to patients as soon as possible."
The CRL did not identify any issues related to the safety, efficacy, or labeling of ABBV-951, including its delivery device. Furthermore, the FDA did not request any additional efficacy or safety trials related to the drug or device.
About ABBV-951
ABBV-951 (foscarbidopa/foslevodopa) is a solution containing prodrugs of carbidopa and levodopa. It is designed for continuous subcutaneous infusion over a 24-hour period to manage motor fluctuations in adults with advanced Parkinson's disease (搜索). The drug has already been approved in 34 countries, with over 2,100 patients worldwide having initiated treatment. AbbVie (搜索) is actively collaborating with regulatory bodies globally to expand the availability of ABBV-951 to individuals with advanced Parkinson's disease.