Teva Receives Complete Response Letter for Rare Disease DrugBy
Teva Pharmaceutical Industries Ltd. has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application (NDA) for SD-809 (deutetrabenazine) tablets for the treatment of chorea associated Huntington disease (HD). 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.
SD-809 (deutetrabenazine) is an investigational, oral, small-molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is being developed for the treatment of chorea associated with HD. Deutetrabenazine has been granted orphan drug designation for the treatment of HD by the FDA. Teva is also investigating the potential of deutetrabenazine for treating tardive dyskinesia, for which the FDA has granted a breakthrough therapy designation, and for tics associated with Tourette syndrome, for which the FDA has granted orphan status for pediatric use. Deutetrabenazine uses Teva's deuterium technology.
Source: Teva Pharmaceutical Industries