The FDA has rejected a new Parkinson’s drug from AbbVie for a second time.
Regulators turned away ABBV-951, a 24-hour infusion therapy to treat advanced Parkinson’s disease, AbbVie said Tuesday morning. Back in March 2023, the FDA issued a CRL, requesting more information about the product’s infusion pump device.
In a press release, AbbVie said the FDA found issues during an inspection of a third-party manufacturing site. There were no issues related to the drug or the pump device, and no new studies would need to be conducted, AbbVie said.
AbbVie hadn’t provided an exact PDUFA date, but the company resubmitted its application last December and said it expected a decision by the end of June.
It wasn’t immediately clear Tuesday morning what AbbVie’s next steps would be. A company spokesperson said AbbVie has no information beyond the press release and that the company will continue to work with the FDA.
ABBV-951 comprises prodrugs of levodopa and carbidopa, two widely-used drugs in Parkinson’s, and is administered through a 24-hour infusion pump for patients with advanced disease who don’t respond well to oral treatment. It’s designed to activate once it enters the bloodstream.
The drug was conceived as another option for Parkinson’s patients before potentially facing deep brain stimulation surgery, trial investigator Robert Hauser told Endpoints News. Individuals with advanced disease sometimes undergo such surgery because the effectiveness of levodopa and carbidopa wanes over time.
“Our main choice has been to move on to surgery, deep brain stimulation, or delivery of levodopa enterally [through the stomach],” Hauser said.
The program read out a positive Phase 3 in October 2021, where it succeeded on the primary endpoint of change in baseline “on” time without involuntary movements after 12 weeks. The average increase was 2.72 hours of “on” time for patients taking ABBV-951 and 0.97 hours among those on standard of care, good for a p-value of p=0.0083. Hauser noted he considers this a “relatively large improvement.”
ABBV-951 also decreased “off” time — a secondary endpoint — by an average of 2.75 hours compared to 0.96 hours in the standard of care group, with a p-value of p=0.0054.
Despite the rejection, AbbVie could soon bring a different Parkinson’s drug to market. Cerevel Therapeutics, which announced plans to be acquired by AbbVie in December, reported a Phase 3 win in Parkinson’s in April for tavapadon when given on top of levodopa. Two monotherapy trials for tavapadon remain ongoing, and the acquisition is expected to close in the middle of this year.
Editor’s note: This story has been updated with comments from an AbbVie spokesperson.