FDA Accepts Resubmission of Teva's Huntington Disease Drug
OCTOBER 20, 2016
James Radke, PhD
If at first you don’t succeed, try try again.
Teva Pharmaceutical Industries announced that the FDA has accepted the resubmission of the New Drug Application (NDA) for SD-809 (deutetrabenazine) to treat chorea associated with Huntington disease (HD).
The PDUFA date is April 3, 2017.
In May 2016, the FDA sent the company a Complete Response Letter and in that letter, the FDA stated that while no new clinical trials were requested, the FDA had asked that the company to examine blood levels of certain metabolites. Hopefully, that information is part of the new NDA.
Earlier this year, we talked with Samuel Franks, MD of Beth Israel Deaconess Medical Center about the efficacy of SD-809 to treat chorea and dystonia in patients with HD. Click the image below to watch a clip from that interview.
The NDA filing is based on positive results from 2 Phase-3 studies, FIRST-HD and ARC-HD. In the placebo-controlled, randomized FIRST-HD study, SD-809 reduced chorea in patients with HD. Positive top-line data from the Phase-III, open-label ARC-HD study demonstrated that patients were able to safely convert from tetrabenazine, currently the only approved HD treatment, to SD-809 overnight with continued control of chorea.
First-HD was a 1:1 randomized, double-blind, placebo-controlled, parallel-group trial evaluating the efficacy, safety and tolerability of SD-809 in the management of chorea associated with Huntington's disease. The primary efficacy endpoint for the study was the change from baseline to maintenance therapy in the Total Maximal Chorea (TMC) score of the Unified Huntington's Disease Rating Scale (UHDRS and patients taking SD-809 achieved a meaningful improvement of 2.5 points on the TMC score from baseline to maintenance therapy compared to placebo (P < .0001).
In addition, the Phase-3, open-label ARC-HD study demonstrated that patients can safely convert from tetrabenazine, currently the only approved HD treatment, to SD-809 overnight with continued control of chorea.
SD-809 (deutetrabenazine) is an investigational, oral, small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that regulates the level of dopamine. The drug was originally developed by Auspex Pharmaceuticals which was acquired by Teva Pharmacuetical Industries in May 2015.
Huntington disease (HD) is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems. The classic onset of HD symptoms typically occurs in middle age, but the disease also manifests in children and the elderly. HD is the most common genetic cause of abnormal involuntary writhing movements called chorea. Disease progression is characterized by a gradual decline in motor control, cognition and mental stability and generally results in death within 15‐25 years of clinical diagnosis.
Huntington's Disease is an inherited brain disorder that results in the progressive loss of both mental and motor control. Symptoms usually appear between the ages of 30 to 50, and worsen over a 10 to 25 year period until the patient eventually dies. Chorea is the pronounced symptom of the condition.