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18
Aug 2020
New Alzheimer’s drug could be approved for use in US by March 2021
An experimental Alzheimer’s drug will get a fast track review for approval from the US Food and Drug Administration (FDA), according to the treatment’s makers.
If approved, the drug aducanumab would be the first treatment designed to delay progression of the disease.
In studies undertaken last year, the highly-anticipated drug improved brain function for patients who got enough of the medication.
The FDA agreed to an urgent review, with a decision expected to be reached by 7th March 2021, which is faster than the ten months usually expected under a standard review.
Yatin Suneja, Guggenheim analyst, said “For the FDA to come and state that they will try and review it earlier is a pretty big deal.”
Regulators had agreed to fast track the review without the need for a voucher that ensures a fast consideration, which some analysts said could be seen as a sign of FDA interest.
Aducanumab is an antibody drug which seeks and destroys amyloid beta, protein plaques that develop in the brain and are a hallmark of Alzheimer’s disease. Scientists believe that these are at least partially responsible for cognitive decline and memory loss in patients.
The FDA is expecting to hold a meeting of external experts on the application on a yet-to-be-determined date.
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Posted by Tony May, Partner/head of Clinical Negligence Department, Chadwick Lawrence LLP (tonymay@chadlaw.co.uk ), medical negligence lawyers and clinical negligence solicitors in Huddersfield, Leeds, Wakefield and Halifax, West Yorkshire.
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