Cambridge, Massachusetts-based pharmaceutical company Biogen has made a significant decision regarding its Alzheimer’s drug, Aduhelm. The drug, once hailed as a potential blockbuster, is now being discontinued by Biogen, signaling a major shift in their focus and strategy within the Alzheimer’s treatment landscape.
Biogen revealed on Wednesday that it will terminate not only the development of Aduhelm but also the study required for full approval by the Food and Drug Administration (FDA). In addition, the company will cease all sales of Aduhelm, marking the end of a tumultuous journey for the controversial drug.
Patients who are currently taking Aduhelm doses available through the commercial market will be allowed to continue their treatment until November. Approximately 2,500 individuals worldwide are using Aduhelm, but with its discontinuation, they will need to explore alternative treatment options.
Biogen’s decision comes after Aduhelm faced significant challenges and scrutiny since its introduction as the first new Alzheimer’s drug in nearly two decades. Initially priced at a staggering $56,000 per year, Aduhelm failed to meet expectations and generate the expected billions in revenue for Biogen.
One of the key factors behind Aduhelm’s underperformance was the reluctance of doctors to prescribe it due to weak evidence suggesting it effectively slowed the progression of Alzheimer’s. Insurers also imposed restrictions and limitations on coverage, further complicating its adoption. The federal government’s Medicare program, which covers patients aged 65 and older, imposed strict criteria for eligibility, posing a significant hurdle for Biogen since most Alzheimer’s patients fall within this demographic.
As a result, Aduhelm’s quarterly sales fell far short of initial projections, forcing Biogen to drastically scale back its marketing efforts in 2022. Additionally, last year, Biogen sought external financing or partnerships to support the Aduhelm program, but those efforts ultimately proved unsuccessful.
Biogen’s decision to discontinue Aduhelm is part of a broader strategic shift towards other Alzheimer’s treatments. The company is now redirecting its resources and attention to alternative therapies for this devastating and mind-robbing disease. Notably, Biogen is also collaborating with Japanese drugmaker Eisai to promote another Alzheimer’s treatment called Leqembi.
Leqembi holds the distinction of being the first medication to convincingly demonstrate a modest ability to slow cognitive decline in patients affected by Alzheimer’s disease. Regulators have granted full FDA approval for Leqembi, specifically for individuals with mild dementia and other early Alzheimer’s symptoms.
In response to the discontinuation of Aduhelm, Biogen is expected to book a charge of approximately $60 million in its fourth-quarter financial report, reflecting the costs associated with shutting down the Aduhelm program.
Despite the decision to halt Aduhelm, Biogen’s shares experienced a positive response in the market, climbing more than $4 to $251.72 on Wednesday morning, while the broader Standard & Poor’s 500 index saw a decline. This decision marks a pivotal moment for Biogen as it shifts its focus within the Alzheimer’s treatment landscape, emphasizing alternative solutions to combat this devastating disease.