The U.S. Food and Drug Administration has declined to approve ABBV-951 for patients with Parkinson's disease due to problems at a third-party manufacturer, marking the second rejection for the treatment.
The drug' manufacturer, AbbVie, noted the FDA had not identified issues with the therapy's safety or efficacy and did not request additional trials.
ABBV-951 is a version of carbidopa-levodopa, the standard of care for the disease. It is administered subcutaneously, or under the skin, through an infusion pump in order to improve patients' motor functions. The therapy was being tested to treat patients with advanced Parkinson's disease which causes muscle rigidity and slowness of movement.
A complete response letter was issued by the FDA indicating the company's marketing application would not be approved by the agency in its current form due to "observations that were identified during inspection of a third-party manufacturer," Abbvie said. Last year, the regulator declined to approve the therapy and requested additional information on the device used to administer the treatment.
If approved, analysts estimate $619.67 million in sales for ABBV-951 in 2026, according to LSEG data. AbbVie said it will continue to work with the FDA. Shares of the company are down marginally in early trade.