Biogen tweaks confirmatory trial of Alzheimer’s drug Aduhelm

by Stephen Riddle

Biogen and Eisai have increased the earning potential of their Alzheimer’s drug Aduhelm by expanding the post-marketing trial of the drug required by the FDA – which could be the primary source of income for the drug.

If the provisional reimbursement decision by the Centre for Medicare and Medicaid Services (CMS) is finalised, Aduhelm (aducanumab) will only be covered for certain patients enrolled in clinical trials. And while that only applies to patients receiving the drug via the federal healthcare schemes, it’s quite possible private insurers will follow the CMS’ lead.

With that brake on take-up in the offing, Biogen and Eisai’s decision to expand the size of the ENVISION confirmatory study by 200 to 1,500 subjects could be seen as a way to boost near-term revenues for Aduhelm as they try to convert the FDA’s conditional okay for the drug to a full approval.

Biogen and Eisai have emphasised other reasons for the expansion, including strengthening the data that will be provided by the study – due to readout in around four years’ time – and increasing the diversity of subjects, with a target of 18% black/African American and Latinx populations.

“This goal matches the diversity among Americans diagnosed with early Alzheimer’s disease, while at the same time, the trial will generate substantial data to verify the effectiveness of Aduhelm,” said Biogen’s head of global safety and regulatory sciences Priya Singhal, who is acting head of R&D following the departure of Al Sandrock.

Subjects in the trial will also have to have evidence of amyloid plaques at enrolment as well as mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s disease, something that was required in the CMS’ initial decision but not the approved FDA labelling for Aduhelm.

Another change means that the primary endpoint for the trial will be the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at 18 months after treatment starts with the drug – the same endpoint that was used in Biogen and Eisai’s two phase 3 trials – EMERGE and ENGAGE – which generated mixed results.

Referring to the CMS draft, Biogen said that it is “committed to engaging with CMS to avoid unnecessary duplication of clinical trials and work towards finding a path to offer immediate access to patients to the first FDA approved treatment for Alzheimer’s disease since 2003.”

The CMS’ decision to restrict the drug came despite Biogen slashing the cost of Aduhelm in half to $28,200 a year, acknowledging that it had made a mistake in its initial pricing level. A final decision by the agency is expected by 12 April.

ENVISION is due to get underway in May. Meanwhile, Biogen and Eisai are also running a real-world study called ICARE AD that aims to provide information on the long-term effectiveness and safety of Aduhelm as used in clinical practice in around 6,000 patients.

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