The global biotechnology company Biogen has recently indicated it has terminated an observational study of its approved Alzheimer’s disease (AD) drug aducanumab, following its post on ClinicalTrials.gov. The company noted in the details that the termination of the phase IV ICARE-AD trial was “a result of the national policy for coverage, it is expected there will be limited aducanumab-avwa prescription and usage in routine clinical practice, making the study not feasible for enrolment.” The trial was to be a prospective, single-arm, multicentre, non-interventional study of aducanumab as prescribed in the post-marketing setting in the US. Participants would receive aducanumab and be followed up to five years. The study was designed to enrol 6,000 participants with AD in the US, but only 29 had joined over a seven-month period. This follows the April announcement from the Centers for Medicare and Medicaid Services (CMS) on aducanumab and future monoclonal antibodies directed against amyloid that might be approved by the FDA for the treatment of AD.
The decision is ultimately that Medicare will be able to cover the cost of aducanumab only for participants enrolled in qualifying clinical trials. The FDA approved aducanumab last year in US under an accelerated approval pathway, based on clinical trial data showing that aducanumab could reduce amyloid plaques in the brains of people treated with the drug. Biogen is still running the Phase IV ENVISION post-marketing study, conducted as a part of aducanumab’s accelerated FDA approval. The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo. The study plans to enrol about 1,500 participants with early AD and confirmation of beta-amyloid pathology. https://www.biospace.com/article/biogen-abandons-real-world-study-of-alzheimer-s-drug-aduhelm/
