The U.S. Food and Drug Administration has approved Biogen's aducanumab, the first drug to target an underlying cause of Alzheimer's disease. The drug, to be sold under the brand Aduhelm, is the first new approval of an Alzheimer's drug since 2003 and the only treatment designed to slow progression of the mind-robbing disease.
The FDA approved Aduhelm for the treatment of Alzheimer's disease. The decision did not define the patient population for whom the treatment is appropriate.
The drug was tested in patients in the earliest stages of Alzheimer's - before the disease has made a major impact in their ability to care for themselves. It was not tested in people who had progressed to moderate dementia, a stage in the disease in which patients start to lose the ability to care for and feed themselves., a top U.S.
Patients who are prescribed Aduhelm will likely need both cognitive testing and confirmation that their dementia is due to Alzheimer's, through either a lumbar puncture to examine spinal fluid or through a special brain scan to confirm the presence of amyloid in the brain.Aduhelm is designed to target amyloid beta, a protein that forms sticky deposits or plaques in the brains of patients with Alzheimer's disease.
The drug is designed to slow the progression of Alzheimer's disease, allowing patients to remain as self-sufficient as possible for as long as possible. It is not a cure.Most patients will likely need to receive the treatment at specialty infusion centers. Biogen said in April that it was working with 600 U.S. centers to prepare for the pending launch of the drug. The drug is expected to be prescribed by Alzheimer's specialists.Yes.
Patients may also have to pay part of the cost of diagnostic testing and tests for monitoring side effects.Subscribe for our daily curated newsletter to receive the latest exclusive Reuters coverage delivered to your inbox.
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