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Biogen plans confirmatory trial as FDA documents show struggle over Aduhelm approval

Confirmatory trial is planned to be completed ahead of nine-year time frame

Biogen has responded to questions from the Alzheimer’s disease community regarding its Eisai-partnered anti-amyloid drug Aduhelm, as recently revealed memos show a struggle within the US Food and Drug Administration (FDA) over the drug's approval.

In an update, Biogen and Eisai said that they were ‘committed’ to responding to questions from the Alzheimer’s community and the companies shared some new information on the status of a confirmatory trial, the results of which will determine the continued approval of Aduhelm (aducanumab) as a treatment for Alzheimer’s disease.

The companies said they were ‘urgently’ working to put resources and plans in place to ensure the completion of the confirmatory trial ahead of the nine-year time frame.

This includes advancing the design of the trial protocol, with Biogen and Eisai adding that they plan to engage with regulators, investigators and other stakeholders as they move forward towards patient enrolment.

In the update, Biogen and Eisai said that it is important to note that Aduhelm has only been studied in patients with early symptomatic Alzheimer’s disease, representing an estimated patient population for Aduhelm of approximately one to two million people, according to the companies.

However, they highlighted that it is not expected that all of these patients will be treated with Aduhelm – ‘for a variety of reasons’ – adding that they expect patient uptake to be gradual over the next few years.

In response to the launch price of Aduhelm – $56,000 per year of treatment – Biogen and Eisai said that the price is based “on our belief in the impact of treatment as well as the size of the appropriate patient population”.

They added: “In the event that our fundamental assumptions on population size and rate of adoption are significantly different than expected, we stand ready to work with public and private payers to address pricing in order to achieve both patient access and support budget sustainability.”

The update comes after memos were recently revealed from the FDA, showing that there was an internal struggle over the approval of Aduhelm earlier this month.

The approval came as a surprise to many industry watchers and experts, particularly as an independent advisory panel had voted against approval of the drug last year.

Since the approval, three members of that panel have resigned, including Aaron Kesselheim, a professor of medicine at Harvard Medical School, who said the authorisation “was probably the worst drug approval decision in recent US history”.

The memos, according to Reuters, shows disagreements within the FDA over whether to approve Aduhelm using the accelerated approval pathway or a regular approval pathway.

Ultimately, the FDA granted Aduhelm an accelerated approval, meaning that a confirmatory study is needed to ensure the drug can continue to be used to treat certain Alzheimer’s disease patients.

Article by
Lucy Parsons

23rd June 2021

From: Healthcare



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