FDA asks Teva for further study on Huntington drug candidate
Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) said the US regulators have put on hold the approval for its drug to treat chorea caused by Huntington disease (HD) and asked for additional blood study.
The company said it received a letter from the Food and Drug Administration (FDA) for the drug compound SD-809, to treat chorea, or abnormal, involuntary writhing movements that occur in 90% of HD patients at some point in the course of their illness.
The world’s largest generic drug firm said the FDA has asked it to examine blood levels of certain metabolites. These metabolites are not novel, and are the same seen in subjects who take tetrabenazine or deutetrabenazine. No new clinical trials have been requested, the company said in a statement.
Michael Hayden, chief scientific officer at Teva, said: “We are accelerating the re-analysis process we were asked to conduct. We plan to submit our response to the CRL in Q3 2016.”
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