Biogen, the biotechnology company behind the Alzheimer’s drug Aduhelm, announced on Wednesday that it would stop selling and developing the drug, which had faced criticism and skepticism from the medical community and regulators since its launch in 2021.
Aduhelm’s Rocky Journey
Aduhelm, also known as aducanumab, was the first new drug for Alzheimer’s disease in nearly two decades. It was designed to target amyloid beta, a protein that forms sticky plaques in the brains of Alzheimer’s patients, and slow down the progression of the disease.
The drug received accelerated approval from the Food and Drug Administration (FDA) in 2021, despite mixed results from clinical trials and opposition from an advisory panel of experts, who voted overwhelmingly against its approval. The FDA said that the drug showed a “reasonably likely” benefit for Alzheimer’s patients, but required Biogen to conduct a confirmatory study to prove its effectiveness.
However, the approval sparked controversy and backlash from many doctors, scientists, and patient advocates, who questioned the drug’s safety, efficacy, and cost. The drug was initially priced at $56,000 per year, which would have added a huge burden to the health care system and the patients, most of whom are covered by Medicare, the federal program for the elderly.
The drug also faced challenges in getting reimbursement and coverage from insurers, who imposed strict criteria and limits on who could get the drug. Medicare, which covers about 6 million Alzheimer’s patients in the U.S., proposed a national coverage policy that would only allow the drug to be prescribed to patients who meet the criteria of the clinical trials, which excluded those with severe dementia or other conditions.
Biogen’s Decision to Discontinue Aduhelm
Biogen said that it decided to discontinue Aduhelm after considering the time and investment required for the confirmatory study, as well as the likely advancements in the field of Alzheimer’s research before the drug could receive full approval. The company said that it would end the study and stop selling the drug by November 2024.
Biogen said that it would return the rights to Aduhelm to Neurimmune, the Swiss company that invented the drug and licensed it to Biogen in 2007. Biogen said that it would work with Neurimmune to ensure a smooth transition and support the patients who are currently taking the drug.
Biogen also said that it would focus on other treatments for Alzheimer’s disease, including another drug called Leqembi, which it co-developed with Eisai, a Japanese pharmaceutical company. Leqembi, also known as lecanemab, received full approval from the FDA in 2023, and is the first drug that has been shown to slow the cognitive decline caused by Alzheimer’s disease, though only modestly. Leqembi targets a different form of amyloid beta than Aduhelm, and is administered as a monthly injection.
The Future of Alzheimer’s Research
Biogen’s decision to stop selling Aduhelm is a major setback for the company, which had invested billions of dollars and more than a decade of research into the drug. It is also a disappointment for many Alzheimer’s patients and their families, who had hoped for a breakthrough treatment for the devastating disease, which affects more than 6 million Americans and has no cure.
However, Biogen’s decision also opens up new opportunities and challenges for the field of Alzheimer’s research, which has been plagued by failures and frustrations for years. Many researchers and experts have argued that targeting amyloid beta alone is not enough to treat Alzheimer’s, and that other factors, such as inflammation, tau protein, and genetics, need to be addressed as well.
The FDA’s approval of Aduhelm also raised questions about the standards and processes of drug regulation, and the role of patient advocacy and industry influence in shaping the decisions. The FDA’s acting commissioner, Janet Woodcock, requested an independent investigation into the approval of Aduhelm, amid allegations of irregular communication and collaboration between the agency and Biogen. Several members of the advisory panel that voted against the drug resigned in protest after the approval.
The future of Alzheimer’s research will depend on finding new ways to understand the causes and mechanisms of the disease, developing more reliable and accurate biomarkers and diagnostic tools, and testing more diverse and innovative therapies that can address the multiple aspects of the disease. It will also require more collaboration and transparency among the stakeholders, including researchers, regulators, industry, and patients, to ensure that the best science and evidence guide the development and approval of new drugs.
