Medicare Alzheimer’s Decision Varies Evidence Mandate For Accelerated vs. Traditional Approvals
Final Medicare national coverage determination aims to set up a ‘nimble’ system to allow for broad and rapid patient access to drugs for Alzheimer’s disease following traditional approval while retaining a more restrictive approach for accelerated approvals.
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Aduhelm commercialization was a bust, so Biogen’s next big hope for a potential blockbuster Alzheimer’s therapy is partner Eisai’s amyloid protofibril-targeting antibody lecanemab.
The company will prioritize later-stage R&D, including potential accelerated approval for a second anti-amyloid antibody, while replacing its CEO and cutting Aduhelm commercial operations and other costs.
New safety information may help defense of CMS's coverage restrictions. FDA updated the prescribing information for Biogen’s Alzheimer's therapy after four cases of seizures were reported in a trial.