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 Teva, the world's largest generic drugmaker, said it received a
letter from the 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.
(Reporting by Steven Scheer; Reporting by Tova Cohen)
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