Biogen has not given up on early access for Aduhelm
US Food and Drug Administration approval may have felt like the finishing line, but a long and winding road to reimbursement still stretches ahead for Aduhelm (aducanumab).
With Medicare refusing to offer the novel Alzheimer’s med outside of the clinical trial setting, data from confirmatory studies could be critical to its future prospects.
Developers Biogen (Nasdaq: BIIB) and Eisai (TYO: 4523) have now released details of their plans for Phase IV research, designed to convert their US FDA Accelerated Approval into regular authorization.
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