Loading ...

Biogen's announcement On January 31 that it will discontinue development and commercialization of the anti-amyloid agent, aducanumab (Aduhelm), for Alzheimer's disease (AD) came as no surprise to many experts in the field. 

"Clearly, the drug was a commercial failure," Dave Knopman, MD, professor of neurology, Mayo Clinic, Rochester, Minnesota, told Medscape Medical News. "Despite the accelerated approval, the uncertainty of clinical benefits was transparent, and the public failed to generate any enthusiasm for the drug."

As reported by Medscape Medical News, aducanumab received accelerated approval from the US Food and Drug Administration (FDA) in June 2021 despite a recommendation by its own advisory panel not to approve the drug. Knopman was a member of that panel and one of three members who resigned after the agency's decision to approve the drug. 

"The decision by Biogen to cancel the aducanumab program was not surprising, as the company steadily withdrew their engagement in the program over the past year," Knopman noted. 

"This was a commercial decision — not so much a scientific decision," Howard Fillit, MD, founding executive director of the Alzheimer's Drug Discovery Foundation, told Medscape Medical News. 

"The process by which the [aducanumab] program was handled and some of the conflicting opinions at the FDA led to uncertainty about the efficacy of the drug, and it wasn't being prescribed," Fillit said. 

After its approval, the Centers for Medicare & Medicaid Services restricted coverage of aducanumab to patients enrolled in clinical trials, which experts say likely contributed to Biogen's decision to ditch the drug. 

It also limited the number of people living with AD who could get access to the treatment and "created significant confusion for patients and doctors," the Alzheimer's Association said in a statement on Biogen's decision. 

Biogen will also terminate the post-approval clinical trial known as ENVISION, which sought to confirm aducanumab's benefits in patients with early AD. 

Going forward, Biogen said that it will now focus on advancing lecanemab (Leqembi), the first anti-amyloid to receive traditional FDA approval.

"We have learned much from the mistakes and misjudgments that plagued aducanumab, but the field has moved on and is a little the wiser," Knopman said. "With the standard approval of lecanemab, which showed clear, albeit modest, clinical benefits, we are focusing on providing safe and efficient access to lecanemab." 

Biogen plans to accelerate the development of potential new treatment modalities. These include BIIB080, an investigational antisense oligonucleotide therapy targeting tau, and BIIB113, an oral small-molecule inhibitor of tau aggregation.

Fillit said that he's "very excited" about the current pipeline of AD drugs, starting with donanemab, which is currently under review at the FDA, and "looks like it has somewhat better efficacy data than lecanemab."