By Colin Kellaher


The U.S. Food and Drug Administration has once again turned away AbbVie's proposed next-generation therapy 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 on Tuesday 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.

The biopharmaceutical company 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 already uses the combination of carbidopa and levodopa in the Parkinson's treatment Duopa, a gel that is administered with a pump through a stomach tube.

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.-based company, which was hoping to finally win an FDA green light for ABBV-951 this year, has said it sees a peak sales opportunity topping $1 billion plus for the product.

AbbVie currently markets ABBV-951 as Produodopa in Europe and Vyalev in Canada. The drug is been approved in 34 countries, and more than 2,100 patients worldwide have started treatment, the company said.

AbbVie said it continues to work with the FDA to bring ABBV-951 to the U.S. market as quickly as possible. A representative said the company doesn't currently have a timeline for a new FDA submission.


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


(END) Dow Jones Newswires

06-25-24 1220ET