At a J.P. Morgan Healthcare panel on January 11, representatives for Biogen cited Eli Lilly’s positive Phase 2 study of Alzheimer’s drug donanemab as a good sign for the FDA approval of their own drug, aducanamab. Both treatments are monoclonal antibodies targeting the amyloid-β peptide that constitutes the plaques found in Alzheimer’s disease.

Biogen had initially abandoned its two Phase 3 studies of aducanamab in 2019 due to disappointing outcomes. After another analysis of the data, the company concluded that one of the studies had yielded positive results and that factors like a change in dosing accounted for the discrepancy between the two otherwise identical trials.

This conflicting data led an advisory panel for the FDA to vote against approving aducanamab last November. When the FDA makes its official decision early this March, it may or may not heed the panel’s recommendation.

Consumer advocacy group Public Citizen has criticized the closeness with which the FDA has worked with Biogen throughout the this process, citing among other things a joint briefing document about the drug released by the agency and Biogen. Describing this relationship as as an instance of regulatory capture, Public Citizen sent a letter to the  U.S. Department of Health and Human Service’s Office of Inspector General demanding an investigation into the aducanamab approval process last December.

Thus far, there is no indication whether such an investigation will take place.