Tags: Alzheimer's/Dementia | Alzheimers disease | FDA | ELND005 | neuropsychiatric | symptoms

FDA Fast-Tracks Review of Promising Alzheimer's Drug

Thursday, 18 Jul 2013 07:39 AM

Canadian biopharmaceutical company Transition Therapeutics said the U.S. Food and Drug Administration granted a fast-track status to its Alzheimer's drug, sending its U.S.-listed shares up 33 percent in post-market trading.

A fast track designation by the FDA expedites regulatory review of drugs that aim to treat serious diseases and fill unmet medical needs.
 
The drug, ELND005, currently being tested in a mid-stage trial, treats neuropsychiatric symptoms such as agitation or aggression in Alzheimer's disease.
 
Transition Therapeutics said the drug appeared to decrease the emergence and severity of specific neuropsychiatric symptoms in a previous mid-stage study.
 
About 90 percent of Alzheimer's patients develop neuropsychiatric symptoms and up to 60 percent develop agitation over the course of their disease, the company said.
 
Ireland-based Elan Corp Plc is Transition's marketing and development partner.
Transition Therapeutics' Toronto-listed shares closed at C$3.15 (U.S. $3.02) on Wednesday.

© 2015 Thomson/Reuters. All rights reserved.

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Canadian biopharmaceutical company Transition Therapeutics said the U.S. Food and Drug Administration granted a fast-track status to its Alzheimer's drug, sending its U.S.-listed shares up 33 percent in post-market trading.A fast track designation by the FDA expedites...
Alzheimers disease,FDA,ELND005,neuropsychiatric,symptoms
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