FDA Rejects Teva's Application for Huntington's Drug -- 3rd Update

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.

Several analysts who cover Teva said they still expect the drug to eventually be approved.

"We expect an approval in the fourth quarter, which ultimately would translate into a delay of several months," said Randall Stanicky, Managing director at RBC capital markets. "The re-emergence of growth in its specialty branded business is going to be a core part of the upside case for Teva over the next several years. Getting this product to market is an important part of that."

Teva's American depositary shares fell 0.3% to $51.52 in morning trading.

Write to Austen Hufford at austen.hufford@wsj.com

(END) Dow Jones Newswires

May 31, 2016 12:14 ET (16:14 GMT)

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