Teva Gets CRL From FDA For NDA For SD-809 Tablets For Chorea Associated With HD

(RTTNews) - Israel-based pharmaceutical company Teva Pharmaceutical Industries Ltd. (TEVA) Tuesday said it received a Complete Response Letter, or CRL, from the U.S. Food and Drug Administration regarding the New Drug Application, or NDA, for SD-809 tablets for the treatment of chorea associated Huntington disease or HD. This is the first deuterated product to be reviewed by the FDA.

Teva has been asked by The FDA 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.

Michael Hayden, Teva's President of Global R&D and Chief Scientific Officer, said, "Teva will continue to work closely with the FDA to bring SD-809 to the market as quickly as possible."

HD is a rare and fatal neurodegenerative disorder caused by the death of nerve cells in the brain that affects about one in 7,000 - 10,000 people in western countries. Chorea—abnormal, involuntary writhing movements—is one of the most striking physical manifestations of this disease and it occurs in about 90% of patients at some point in the course of their illness.

In addition to Huntington disease, Teva said programs for the development of SD-809 for the treatment of patients with tardive dyskinesia (TD) and Tourette syndrome (TS) are ongoing.

SD-809 has also been granted orphan drug designation for the treatment of TS in the pediatric population and is planning further evaluation of SD-809 as a treatment for tics associated with TS.