FDA Again Hits AbbVie Parkinson’s Treatment With Complete Response Letter

 The FDA has again denied AbbVie’s New Drug Application for its ABBV-951 Parkinson’s treatment due to issues with a third-party manufacturer. The pharma announced Tuesday that it received a Complete Response Letter from the regulator. 

AbbVie emphasized the Complete Response Letter (CRL) did not reveal any issues with the safety or efficacy of ABBV-951 or its administration device, and that the FDA is not requesting that AbbVie conduct additional efficacy and safety trials related to the drug or device-related testing. The FDA’s CRL cited observations from an inspection of the third-party manufacturer’s facility that did not involve any AbbVie medicines, according to the company. 

“We are focused on working with the FDA to bring this important therapy to patients as soon as possible,” AbbVie CMO Roopal Thakkar said in a statement. 

ABBV-951 is a solution of two prodrugs—cabidopa and levodopa—and is administered subcutaneously in a 24-hour continuous infusion to treat motor fluctuations in patients with advanced Parkinson’s disease. Approved in over 34 countries, this latest regulatory roadblock is the second for AbbVie in its quest for U.S. approval. 

In March 2023, the FDA issued the first CRL for AbbVie’s New Drug Application (NDA) for ABBV-951. The issue at the time involved the pump used to administer the infusions and not the drug itself. The regulator requested additional information on the pump as part of its review. AbbVie resubmitted its NDA in December 2023.  

The company’s next steps in addressing the FDA’s latest rejection were not detailed in Tuesday’s announcement beyond the company’s statement that it is working with the agency to bring the drug to U.S. patients “as quickly as possible.” 

ABBV-951 isn’t AbbVie’s only potential Parkinson’s treatment seeking approval. After signing a deal to scoop up Cerevel Therapeutics in December 2023 for $8.7 billion, the biopharma reported topline data in April 2024 from a Phase III of tavapadon used in combination with levodopa. 

The trial endpoint tested the total “on time” for patients, when they can move and function without dyskinesia. The combination provided patients with a nearly three times greater effect than levodopa alone. Cerevel said at the time that the data readout would support regulatory submission. The AbbVie acquisition is expected to close in mid-2024. 

https://www.biospace.com/article/fda-again-hits-abbvie-parkinson-s-treatment-with-crl-/