Biogen and Eisai have presented new data for their Alzhimer’s disease treatment Aduhelm at the Alzheimer’s Association International Conference (AAIC) following the controversial approval of the drug last month.
The companies presented four posters on Aduhelm (aducanumab) at AAIC, which included item-level data from the phase 3 EMERGE trial.
This data included analysis on individual domains used for the trial’s pre-specified endpoints – this showed that high-dose Aduhelm treatment demonstrated consistent effects across all six domains including cognitive and three functions as measured by the Clinical Dementia Rating-Sum of Boxes.
An additional poster presentation considered the decrease in amyloid beta(AB) plaques and downstream biomarkers of Alzheimer’s across Aduhelm cohorts in three clinical trials, while another set of analyses evaluated the relationship between treatment effects and AB plaque levels.
“Our presentations to the dementia research community at AAIC of this robust set of clinical trial data will allow us to engage directly with scientists and neurologists on in-depth analyses of our findings,” said Alfred Sandrock head of research and development at Biogen.
Meanwhile, Biogen has withdrawn a paper it recently submitted to JAMA which analysed clinical trial results for Aduhelm after the top medical journal considered rejecting it unless edits were made, Axios reported on Tuesday, citing two sources familiar with the matter.
In response, Biogen said: “JAMA did not reject the publication. Biogen withdrew the publication from JAMA and decided to pursue other publication opportunities.”
Before a drug receives approval from the US Food and Drug Administration, late-stage trial data is usually published in a medical journal, although this wasn’t the case for Aduhelm.
Critics have taken issue with what appears to be contrasting results from two late-stage trials evaluating Aduhelm – known as EMERGE and ENGAGE.
While EMERGE gave a positive if modest readout for the high-dose Aduhelm arm on cognition scores, ENGAGE didn’t show clinical efficacy for the drug and the general consensus seemed to be that the dataset didn’t meet the FDA’s usual criteria for approval.
Earlier this month, the FDA’s acting commissioner Janet Woodcock called for an independent review into the agency’s approval of Aduhelm.
Woodcock has asked for the process for review of Biogen’s biologics licence application (BLA) for Aduhelm to be investigated. This will include an ‘ongoing focus on interactions’ between Biogen and FDA staff during the review process.
The independent review will aim to determine if any of those interactions were inconsistent with FDA policies and procedures.