After facing challenges, Biogen is discontinuing development and sales of aducanumab (Aduhelm) and focusing on lecanemab (Leqembi).
Biogen has officially announced its decision to discontinue all development and sales of aducanumab (Aduhelm) for Alzheimer disease, over 2 years since its accelerated approval by the US Food and Drug Administration (FDA).1 Instead, Biogen will switch efforts to focus on lecanemab (Leqembi) with partners Eisai, and other treatment modalities in the pipeline, including BIIB080 and BIIB113.
“When searching for new medicines, one breakthrough can be the foundation that triggers future medicines to be developed," said Biogen CEO Chris Viehbacher. "Aduhelm was that groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the field.”
Biogen is also terminating the ENVISION clinical study, which endeavored to confirm the benefit of aducanumab as required by the FDA under its 2021 accelerated approval. Resources freed by this decision will be funneled toward other Alzheimer developments.
Aducanumab, the first drug on the market to target the underlying disease pathophysiology rather than symptoms, had a troubled journey, despite its accelerated beginning.2 Although patient groups applauded its approval, experts recommended caution, with an FDA independent advisory committee preemptively voting against approval in November 2020.3 Additionally, its hefty price tag and limited insurance coverage made it difficult to access for patients. Lecanemab, on the other hand, received breakthrough therapy designation from the FDA in July 2021, then full FDA approval in July 2023, and has been generally better received than aducanumab.2,4
“We are grateful for Biogen’s leadership and continued commitment to the fight against Alzheimer’s. They are true partners in this cause,” said George Vradenburg, UsAgainstAlzheimer’s chair and cofounder. “Fortunately, there is another drug, Leqembi, on the market patients can access and another, donanemab, we hope will soon receive traditional approval by the FDA. We look forward to the day patients and doctors will have multiple options to choose from as they consider their treatment options.”5
This decision by Biogen comes at the heels of a strategic review in 2023, which determined that the ENVISION study and other aducanumab efforts were unsustainable due to lack of external partners and financing. Viehbacher was brought in as CEO at the end of 2022 by Biogen’s board after aducanumab failed to gain enough revenue in 2022 ($13 million) and the company saw stock price declines after the drug’s accelerated approval.1