The pharmaceutical company, Biogen, announced this week that it will stop developing and marketing the Alzheimer’s drug aducanumab (commercially known as Aduhelm).
Aducanumab is designed to target and clear amyloid, one of the hallmark proteins that builds up in the brains of people with Alzheimer’s, at an early stage of the disease. This is similar to the mode of action of newer Alzheimer’s drugs, lecanemab – also made by Biogen – and Eli Lilly’s donanemab.
Aducanumab was made available to people living with Alzheimer’s in the US in June 2021, but was not approved for use in Europe and the UK after the EU drug regulator, the European Medicines Agency (EMA), declined to licence it. The EMA ruled that results from clinical studies were conflicting, and did not show overall that the drug was effective at treating people with early Alzheimer’s disease. In addition, concerns were raised that the studies did not show that the medicine was sufficiently safe.
Biogen says it will now “reprioritise resources allocated to aducanumab to advance lecanemab and to develop new treatments.” Biogen is a co-developer of lecanemab, which was granted full approval in the United States last year. A regulatory decision on lecanemab for use in the UK is likely to be made in the first half of 2024.
Commenting on the announcement, Katie Puckering, Information Services Manager at Alzheimer’s Research UK said, “this means that all patients currently taking aducanumab will end their treatment, including those accessing the treatment through medical services in the US, and those currently taking part in the global ENVISION phase IV clinical trial.”
A Biogen representative said that patients currently taking aducanumab will be able to continue until November 2024. There are about 2,500 people worldwide taking the drug, including 12 people in the UK who are currently enrolled on the ENVISION study.
“Whilst the withdrawal of aducanumab from the market may appear negative, we have seen with many other diseases that early generation of drugs are often replaced by more effective successors,” said Puckering. “Lecanemab, which is marketed in the US under the name Leqembi, may be available to patients currently taking aducanumab in the US. Lecanemab works in a similar way to aducanumab, but clinical trials showed it is more effective at slowing down cognitive decline in people with Alzheimer’s.”