REUTERS — Israel-based Teva Pharmaceutical Industries said on Tuesday approval for a drug to treat chorea stemming from Huntington disease has been held up by U.S. regulators seeking further blood study.
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Teva, the world's largest generic drugmaker, said it received a letter from the U.S. Food and Drug Administration for SD-809 for the treatment of chorea — abnormal, involuntary writhing movements that occur in 90 percent of HD patients at some point in the course of their illness.
"The FDA has asked Teva 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," Teva said.
It added that it would work closely with the FDA to bring the drug to market as quickly as possible.
"We are accelerating the re-analysis process we were asked to conduct. We plan to submit our response ... in the third quarter of 2016," said Michael Hayden, Teva's chief scientific officer.