In one of the most drastic shifts in fortune in the pharmaceutical industry, Biogen has decided to submit its previously failed Alzheimer’s drug for approval. According to the company, The Phase 3 EMERGE (NCT02484547) study met its primary endpoint showing a significant reduction in clinical decline, and Biogen believes that results from a subset of patients in Phase 3 ENGAGE (NCT02477800) study who received sufficient exposure to high dose aducanumab support the findings from EMERGE. According to Bloomberg, the company does not believe it needs to conduct additional trials of the drug before moving ahead.
Here are some of the key takeaways from the company’s new announcement:
The decision to file is based on a new analysis, conducted by Biogen in consultation with the FDA, of a larger dataset from the Phase 3 clinical studies that were discontinued in March 2019 following a futility analysis.
This new analysis of a larger dataset that includes additional data that became available after the pre-specified futility analysis shows that aducanumab is pharmacologically and clinically active as determined by dose-dependent effects in reducing brain amyloid.
In addition, the drug is effective in reducing clinical decline as assessed by the pre-specified primary endpoint Clinical Dementia Rating-Sum of Boxes (CDR-SB).
In both studies, the safety and tolerability profile of aducanumab was consistent with prior studies of aducanumab.
This is big news for patients suffering from Alzheimer’s.
Impact on the Development Landscape:
Currently, more than 200 candidates are under development in the clinical and preclinical stages for the treatment of patients with Alzheimer’s. With over 600 active clinical trials, the research efforts have progressed significantly in this space. Below is a quick snapshot of the development pipeline:
Given the long history of failed drugs in this space, this news comes as a big sigh of relief for drug developers. Below, I have added a quick snapshot showing the history of drug failures in Alzheimer’s diseases:
To get more insights about the Alzheimer’s Disease development landscape, check out the report here.