FDA Again Rejects AbbVie Parkinson’s Treatment

The FDA has once again turned down AbbVie’s New Drug Application for ABBV-951, a treatment intended for Parkinson’s disease, due to problems connected with a third-party manufacturer. Announced on Tuesday, AbbVie disclosed that it had received a Complete Response Letter (CRL) from the FDA.

AbbVie emphasized that the CRL did not indicate any issues related to the safety or efficacy of ABBV-951 or the device used to administer it. Importantly, the FDA is not asking AbbVie to conduct any additional trials for efficacy or safety regarding the drug or the device. The CRL referenced concerns from an inspection of the third-party manufacturer’s facility, which were unrelated to any AbbVie products, as stated by the company.

In response, AbbVie’s Chief Medical Officer, Roopal Thakkar, mentioned, “We are focused on working with the FDA to bring this important therapy to patients as soon as possible.”

ABBV-951 consists of two prodrugs, cabidopa and levodopa, and is delivered subcutaneously via a 24-hour continuous infusion to manage motor fluctuations in patients with advanced Parkinson’s disease. Although this therapy is already approved in over 34 countries, this represents the second regulatory setback for AbbVie in seeking U.S. approval.

Earlier, in March 2023, the FDA had issued the first CRL for the ABBV-951 New Drug Application. The primary concern at that time was related to the pump used for administering the infusions, rather than the drug itself. The FDA had requested additional information about the pump as part of its review process. AbbVie resubmitted its application in December 2023.

The company has not provided detailed plans regarding its next steps to address the FDA’s latest rejection, other than stating its intent to collaborate with the agency to make the drug available to U.S. patients “as quickly as possible.”

ABBV-951 is not the only Parkinson’s treatment that AbbVie is striving to get approved. In December 2023, AbbVie entered into an agreement to acquire Cerevel Therapeutics for $8.7 billion. Following this, in April 2024, the biotech firm reported promising topline data from a Phase III trial of tavapadon used in combination with levodopa.

This trial focused on the total “on time” for patients, which refers to periods when patients can move and function without experiencing dyskinesia. The combination of tavapadon and levodopa showed a nearly threefold improvement compared to levodopa alone. Cerevel stated that the data would support a regulatory submission. The acquisition of Cerevel by AbbVie is anticipated to be finalized by mid-2024.

In conclusion, while facing regulatory hurdles for ABBV-951 in the U.S., AbbVie continues its efforts to expand its portfolio of Parkinson’s treatments, with promising developments on the horizon.