FDA Responds to Teva’s NDA with Complete Response Letter for Huntington’s Chorea Drug

Teva Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) answering the pharmaceutical’s New Drug Application (NDA) for SD-809 (deutetrabenazine) tablets, for the treatment of chorea associated with Huntington’s disease (HD), a condition reported by nearly 90 percent of all Huntington’s patients at some point during the course of their disease.

Based on Teva’s deuterium technology, SD-809 (deutetrabenazine) is an investigational, oral, small-molecule vesicular monoamine 2 transporter (VMAT2) inhibitor, specifically developed for the treatment of HD-associated chorea. Deutetrabenazine had already been granted Orphan Drug Designation for the treatment of Huntington’s disease by the FDA in November 2014.

SD-809 is the first deuterated product that the FDA has reviewed. In its Complete Response Letter, the FDA asked Teva to analyze blood levels of certain metabolites, which are not novel and are similar in subjects who take either tetrabenazine or deutetrabenazine. The FDA has requested no further clinical trials.

Huntington’s disease is a life-threatening neurodegenerative disease triggered by the death of nerve cells in the brain. It affects about one in every 7,000 to 10,000 Western people. Chorea – defined as abnormal and involuntary writhing movements – is one of the most visually striking physical manifestations of the condition.

“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., Teva’s president of global research and development and CSO, in a press release. “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 [later in] 2016.”

Deutetrabenazine is being investigated by Teva for its potential in treating tardive dyskinesia and tics associated with Tourette’s syndrome, for which the FDA has granted Breakthrough Therapy Designation and Orphan Drug Status for Pediatric Use, respectively.