Aduhelm Label Update Includes Seizure Risk And Recommends More MRIs
FDA updated the prescribing information for Biogen’s Alzheimer's therapy after four cases of seizures were reported.
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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.
One patient treated with Aduhelm died who was diagnosed with cerebral edema thought to be ARIA-E, a known risk, Biogen confirmed.
CEO Michel Vounatsos and US president Alisha Alaimo outlined plans to overcome the Alzheimer’s drug’s launch challenges and hinted at lower sales expectations at a Morgan Stanley investor event.