Eli Lilly aims for dementia drug candidate’s approval in 2022; wants to ‘prioritize access’
The Alzheimer’s disease-modifying drug donanemab is on track to be considered for full FDA approval by 2022, its developer said.
Alzheimer’s Disease
First appropriate use guidance published for Alzheimer’s drug Aduhelm
The new guidelines cover how to choose appropriate patients, safely scale up to a full dose, monitor side effects and assess effectiveness. The authors also address when to stop therapy and what patients should not receive the drug.
COVID-19 connected to dementia-like disability, multiple studies find
A bout with COVID-19 can cause dementia-like brain changes and related functional decline, especially for seniors and in people who lose their sense of smell, researchers are finding.
New Alzheimer’s drug Aduhelm has no clinical benefit, panel of medical experts concludes
The drug does not improve upon the current standard of care for Alzheimer’s disease, say advisers to the Institute for Clinical and Economic Review, a drug pricing watchdog.
FDA calls for investigation into its approval of controversial Alzheimer’s drug
The acting chief of the Food and Drug Administration has called for an investigation into the events leading up to the approval of Biogen’s brain plaque-clearing dementia drug aducanumab (Aduhelm).
FDA limits use of new dementia drug Aduhelm to mild cognitive impairment only
The FDA’s new label restricts Aduhelm’s use to Alzheimer’s patients with mild cognitive impairment or mild dementia, drugmaker Biogen announced Thursday.
To save itself, might Medicare deny coverage of controversial new Alzheimer’s drug?
The true price to administer aducanumab — a controversial new Alzheimer’s treatment — may actually be closer to $100,000 annually than other, lower estimates and is just one reason the Centers for Medicare & Medicaid Services could refuse to cover it.
Criticism, confusion and hope: new Alzheimer’s drug receives messy welcome
Clinicians’ responses to the controversial approval of Aduhelm range between excitement and disapproval, with questions abounding on how to advise patients on treatment and the cost to patients and Medicare.
Clinical briefs for Wednesday, June 9
Twist in the FDA’s Alzheimer’s decision: no limits on which patients can get the drug … Biden administration advises changes to policies linked to N95 shortages … Frailty tied to increased mortality in COVID: A living review and meta-analysis … In type 1 diabetes, blood sugar extremes are tied to sixfold risk of dementia … Exercise likely to be best treatment for depression in coronary heart disease … “Immunological memory” protects against COVID re-infection for at least 11 months, analysis shows
FDA approves first drug to slow Alzheimer’s in controversial decision
The evidence convincingly shows that aducanumab (Aduhelm) removes beta amyloid — a hallmark of Alzheimer’s — from the brain, slowing the disease’s progression and giving patients and families much-needed hope, FDA says. But long-term care clinicians are not keen on the drug, with some saying they will not prescribe it.
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