It is the first deuterated product to be reviewed by the FDA. The agency did not request for new clinical trials.
SD-809 (deutetrabenazine) is an investigational, oral, small-molecule inhibitor of vesicular monoamine 2 transporter, which uses Teva’s deuterium technology.
The FDA granted orphan drug designation to deutetrabenazine. Teva is also investigating the potential of deutetrabenazine to treat tardive dyskinesia, for which the agency granted a breakthrough therapy designation.
For tics associated with Tourette syndrome, the FDA granted orphan status for pediatric use.
Teva president of global r&d and chief scientific officer Michael Hayden said: "Teva will continue to work closely with the FDA to bring SD-809 to the market as quickly as possible.
"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.
The company plans to submit its response to the CRL in the third quarter of this year.
HD is a rare and fatal neurodegenerative disorder caused by the death of nerve cells in the brain, affecting nearly one in 7,000 – 10,000 people in western countries.