Biogen’s aducanumab aims to be first DMT approved in 17 years for Alzheimer’s disease, says GlobalData

Following the news that Biogen’s aducanumab seems to reduce disease progression in Alzheimer’s disease (AD) after new data was published from the Phase III trial EMERGE;

Alessio Brunello, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers his view:

“The revaluation of aducanumab by Biogen has come as a surprise as the data published last spring were very disappointing and there was no statistical efficacy shown in the results. However, if these new data are confirmed, aducanumab will represent the first monoclonal antibody (mAb) to demonstrate a statistically significant reduction in amyloid plaque and slowing of cognitive impairment in patients with prodromal or mild AD.

“The AD pipeline has been characterized by big failures as AD drug development is considered to have one of the highest failure rates of all indications. The AD pipeline features 117 drugs across all stages of development in the *7MM, and only 12% of these are in late-stage development. According to GlobalData, the Amyloid precursor protein (Aβ peptide and protein), the microtubule associated protein tau (MAPT), and Beta Secretase1 inhibitors (BACE1) are the major targets being pursued by companies developing drugs against AD.

“GlobalData expected global sales of the drug to be high, equating to $4,686m of sales in 2026 in the *7MM, as there are no disease modifying drugs for this indication. Currently, treatments for AD consist only of symptomatic treatments, of which there are only five approved medications: three cholinesterase inhibitors (ChEIs), one N-methyl-D-aspartate receptor (NMDA-R) antagonist, and one combination therapy.

“Key opinion leaders (KOLs) interviewed by GlobalData were consistently enthusiastic about aducanumab’s potential and identified it as the most promising drug in the AD pipeline. However, its infusion route of administration could be an issue where infusion centers aren’t available and concerns regarding the developing of amyloid-related imaging abnormalities (ARIA) can represent a barrier for the uptake of aducanumab. More data will be needed to clear the concerns from previous trial results, however, the US Food and Drug Administration (FDA) could approve the treatment due to the significant unmet needs in this disease area where no drug has been approved in the past 17 years.”

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