31 May 2016 - Teva Pharmaceuticals today announced that it has received a complete response letter (CRL) from the US FDA regarding the new drug application for SD-809 (deutetrabenazine) tablets for the treatment of chorea associated Huntington disease.

This is the first deuterated product to be reviewed by the FDA. 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 will continue to work closely with the FDA to bring SD-809 to the market as quickly as possible,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “We know that many people in the HD community are waiting for this new medicine. We understand there are very limited treatment options for HD patients and their families, hence we are accelerating the re-analysis process we were asked to conduct. We plan to submit our response to the CRL in Q3 2016."

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 approximately 90% of patients at some point in the course of their illness.

For more details, go to: http://www.tevapharm.com/news/teva_receives_complete_response_letter_for_nda_for_sd_809_for_the_treatment_of_chorea_associated_with_huntington_disease_05_16.aspx