FDA Rejects Teva's Application for Huntington's Drug -- 2nd Update
31 Mai 2016 - 3:07PM
Dow Jones News
By Austen Hufford
The Food and Drug Administration rejected a drug application
from Teva Pharmaceutical Industries Ltd., asking for more
information on the effects of the drug that treats some symptoms of
Huntington's disease.
In a letter, the FDA asked Teva to examine the "blood levels of
certain metabolites" stemming from the use of the drug,
deutetrabenazine. Teva said the impacted metabolites are "not
novel" and are also seen in an already-approved treatment. New
clinical trials haven't been requested. Teva said it would respond
during the third quarter, which ends in the fall.
Huntington's disease is a rare and fatal neurodegenerative
disorder, with involuntary writhing movements known as chorea being
its most visible physical symptom. Teva's drug is trying to limit
the physical movements but doesn't treat the underlying fatal
disease and its other neurological symptoms.
In addition to Huntington's disease, the drug is also being
studied to treat patients with tardive dyskinesia and the tics from
Tourette syndrome.
Teva bought the drug last year when it acquired Auspex
Pharmaceuticals Inc. for roughly $3.2 billion, in a move to boost
its presence in treatments for central nervous system
disorders.
Teva's American depositary shares fell 2.3% to $50.50
premarket.
Write to Austen Hufford at austen.hufford@wsj.com
(END) Dow Jones Newswires
May 31, 2016 08:52 ET (12:52 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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