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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has confirmed its initial recommendation to not consider deutetrabenazine as a new active substance.
In June this year, the CHMP recommended granting a marketing authorization for the medical product Austedo (Teva Pharmaceutical Industries) for the treatment of moderate-to-severe tardive dyskinesia in adults. The CHMP also concluded that the active substance, deutetrabenazine, could not be considered a new active substance — a conclusion that has been confirmed again after re-examination of the initial opinion.
Deutetrabenazine, a nervous system drug, is a reversible inhibitor of the vesicular monoamine transporter 2. While the exact mechanism of deutetrabenazine for the treatment of tardive dyskinesia is unknown, it is believed to relate to its ability to deplete monoamines (such as dopamine, serotonin, and histamine) from nerve terminals. Two randomized, double-blind, placebo-controlled trials found an improvement in the severity of abnormal involuntary movements, assessed by the Abnormal Involuntary Movement Scale, after 12 weeks of treatment.
New draft guidelines on the chemistry of active substances is currently under consultation. Earlier guidelines from 2016 stipulate that a new active substance must not be one that has been previously authorized as a medicinal product in the European Union. To be considered new, it must also be meaningfully different from already-approved substances, taking into account its molecular structure, clinical efficacy, or safety.
