FDA Asks Teva for More Information on Huntington's Drug
31 Mai 2016 - 2:39PM
Dow Jones News
By Austen Hufford
The Food and Drug Administration asked for more information from
Teva Pharmaceutical Industries Ltd. over its application to approve
a 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'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 08:24 ET (12:24 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
Teva Pharmaceutical Indu... (NYSE:TEVA)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024