Biogen (NASDAQ:BIIB), the pharmaceutical company, has announced the discontinuation of its Alzheimer’s drug Aduhelm, once anticipated as a potential blockbuster but facing challenges since its launch a few years ago. Alongside this decision, Biogen will terminate a study crucial for securing full approval from the Food and Drug Administration (FDA).
Patients currently using commercially available doses of Aduhelm will be able to continue until November. Approximately 2,500 individuals worldwide are undergoing treatment with Aduhelm, according to company representatives. Biogen is redirecting its efforts towards other treatments for Alzheimer’s disease and is actively assisting Japanese drugmaker Eisai in promoting Leqembi, an alternative Alzheimer’s treatment that obtained full FDA approval last summer.
Leqembi is distinguished as the first medication conclusively proven to moderately slow cognitive decline in Alzheimer’s patients. Approved for those with mild dementia and early Alzheimer’s symptoms, Leqembi’s effectiveness marks a significant development in Alzheimer’s treatment.
Aduhelm, introduced in 2021 as the first Alzheimer’s drug in nearly two decades, initially garnered attention with its accelerated FDA approval. However, the requirement for an additional study for full approval hampered broad insurance coverage. Priced at $56,000 annually, Aduhelm aimed to slow disease progression rather than merely manage symptoms, positioning it as a potential blockbuster.
Despite early expectations, Aduhelm faced reluctance from physicians due to weak evidence supporting meaningful improvement in patients’ lives. Insurers imposed coverage restrictions, and Medicare, anticipating a surge in Aduhelm claims, initially raised premiums but later scaled back its increase.
Biogen, confronted with the challenge of limited prescription access, generated millions rather than the anticipated billions in quarterly sales. In 2022, the company announced a significant reduction in Aduhelm marketing efforts. Last year, Biogen explored external financing or partnerships for Aduhelm but faced challenges, leading to the current decision.
Apart from Leqembi, another potential treatment option from Eli Lilly and Co. is under FDA review, with a decision expected early this year. Biogen anticipates a charge of approximately $60 million in its fourth quarter due to the discontinuation of the Aduhelm program. Biogen’s shares rose around $4 to $251.11 following the announcement, while the Standard & Poor’s 500 index experienced a slight decline in late-morning trading.
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