By Colin Kellaher


AbbVie on Tuesday said the U.S. Food and Drug Administration has once again turned away its proposed product for controlling motor fluctuations in patients with advanced Parkinson's disease, this time due to concerns about one of the company's third-party manufacturers.

AbbVie said the FDA has issued a so-called complete response letter for ABBV-951, a combination of carbidopa and levodopa prodrugs for continuous infusion through a subcutaneous pump, indicating the agency won't approve the application in its current form.

AbbVie said the FDA cited observations from an inspection that didn't involve ABBV-951 at one of its third-party manufacturing plants, adding that the agency didn't identify any issues related to the safety, efficacy or labeling of ABBV-951, including the device, and didn't request any additional efficacy or safety trials or device-related testing.

AbbVie originally filed for FDA approval of ABBV-951 in May 2022, but the FDA issued a complete response letter in March 2023, seeking additional information on the pump.

The North Chicago, Ill., biopharmaceutical company said it continues to work with the FDA to bring ABBV-951 to the U.S. market as quickly as possible.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

06-25-24 0909ET