Biogen Releases Positive Data on Aduhelm, Takes Over Decision Making

New data show longer-term benefits from Aduhelm, which was approved last year to treat Alzheimer’s disease.

Biogen has released new data showing longer-term benefits of Aduhelm, while the pharma maker simultaneously changed its joint agreement with Eisai on Aduhelm royalties. At the same time, these results were published in the Journal of Prevention of Alzheimer’s Disease.

After nearly two and a half years of treatment with Aduhelm (aducanumab-avwa), patients in the long-term extension phase of the phase 3 trials continued to experience significant reductions in two key Alzheimer’s disease pathologies, Biogen said in a news release.

Data from the long-term extension study showed that Aduhelm significantly reduced amyloid beta plaque levels out to week 132, and that the drug continued to decrease plasma p-tau181 levels at 128 weeks.

Patients with more effective amyloid beta clearance (SUVR lower than 1.1 by 78 weeks) also had greater decreases in p-tau181 at week 128.

“These findings point to the potential of continued benefit of treatment in the longer term with continued reduction of amyloid beta plaques,” Biogen said.

In addition, in both phase 3 trials at 78 weeks, patients with reduced levels of plasma p-tau181 had less clinical decline than those whose plasma p-tau181 levels were not reduced.

“These are meaningful findings, which further our understanding of amyloid and downstream biomarkers, such as p-tau 181, in Alzheimer’s disease, and can help inform how long patients may benefit from treatment to reduce amyloid beta plaque,” said Samantha Budd Haeberlein, Ph.D., senior vice president, head of neurodegeneration development at Biogen. “These data demonstrate that long-term treatment with Aduhelm continues to reduce the underlying pathologies of Alzheimer’s disease beyond two years.”

In related news, Biogen and Elsai amended their existing collaboration agreement on Aduhelm.

Biogen’s existing final decision-making rights on Aduhelm have converted to sole decision making and commercialization rights worldwide, effective immediately.

Eisai will receive a tiered royalty based on net sales of Aduhelm, effective January 1, 2023, rather than sharing global profits and losses. The royalty rate starts at 2% and reaches 8% when annual sales exceed $1 billion.

“This amended collaboration agreement will increase operational efficiency and agility in addressing market developments, including the final determination of CMS on coverage of Aduhelm,” said Biogen CEO Michel Vounatsos.

In June 2021, the FDA granted accelerated approval for Aduhelm as the first Alzheimer’s disease treatment to address a defining pathology of the disease.

The therapy’s approval has been controversial since the beginning. The regulatory agency made the approval even though an advisory committee in November 2020 recommended against it. The controversy surrounding this therapy is related to both the clinical trial results and Biogen's pricing of the therapy.