A new day for Alzheimer’s Disease treatment after FDA approval of Biogen’s Aduhelm, says GlobalData

Following FDA’s approval of Aduhelm (aducanumab) for the treatment of Alzheimer’s Disease (AD), after no new drug for this indication has been approved in the past 18 years despite more than 400 clinical trials and billions of dollars being spent;

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

“Aduhelm is the first therapy to target and affect the underlying disease process of AD. Currently, the available therapies only treat symptoms of the disease, whereas this drug actually works to clear amyloid plaques in the brain. However, the drug faces a few hurdles before it will become available for patients. Its infusion route of administration could be an issue, as infusion centers are not available in all geographic areas. Additionally, concerns regarding the development of amyloid-related imaging abnormalities (ARIAs) represent a barrier for the uptake for Aduhelm. Physicians will also be obliged to do regular MRIs on patients to see if they have ARIA reactions, which could be a limitation, as repeated MRIs represent an additional economic burden. Furthermore, the high cost of USD 50,000 annually may impact reimbursement, which in turn could limit Aduhelm’s uptake.

“Despite these challenges, GlobalData forecasts that Aduhelm will generate $5.5bn globally by 2027.

“The approval of Aduhelm is not a final solution in the treatment of AD, but it could signify a new era for the treatment of the disease. Its approval may also open doors for combination research, namely anti-Aβ therapies with anti tau-therapies. Combination therapy is likely the best path forward for the Aβ inhibitor treatment class, but combination research could not be explored until a drug was approved. The approval could also encourage other developers of amyloid-based therapies to continue testing, and enable them to attract investors to fund much-needed research.

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