TEVA Teva Pharmaceutical Industries Ltd

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 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 08:39 ET (12:39 GMT)

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