Complete Response Letter Issued to First Deuterated Drug Under FDA Review
Teva announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of SD-809 (deutetrabenazine) tablets for the treatment of chorea associated with Huntington's disease (HD). SD-809 is the first deuterated agent to be reviewed by the FDA.
The letter included a request from the FDA to examine blood levels of certain metabolites that are similarly seen in patients receiving tetrabenazine or deutetrabenazine. No new clinical trials have been requested.
SD-809 is also under development for the treatment of tardive dyskinesia (TD) and Tourette syndrome (TS). A Phase 3 clinical trial for patients with moderate to severe TD is currently ongoing. Previously, FDA granted Orphan Drug designation to SD-809 for the treatment of HD and for the treatment of tics associated with TS in the pediatric population.
SD-809 (deutetrabenazine) is an investigational, oral, small-molecule, vesicular monoamine 2 transporter (VMAT2) inhibitor which utilizes Teva's deuterium technology.
For more information call (888) 838-2872 or visit Tevausa.com.