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|April 03, 2017 5:05 p.m.|
|Teva Announces FDA Approval of AUSTEDO™ (deutetrabenazine) Tablets for the Treatment of Chorea Associated with Huntington’s Disease|
Approval represents the first new treatment option for chorea associated with Huntington’s disease in nearly a decade
A rare and fatal neurodegenerative disorder, HD affects more than 35,000
“At Teva, we have a long history of establishing comprehensive disease management programs in chronic disease areas. We have highly skilled teams experienced in building relationships with patients, their care partners and healthcare professionals,” said Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva. “Bringing a new treatment forward where the unmet need is so significant is an inspiring opportunity. Our commercial and medical organizations are well prepared to make this important treatment available to the HD community.”
“Chorea associated with Huntington’s disease has a significant impact on
those living with the disease and their families,” said
Teva’s Shared Solutions® is a free service to provide support to patients starting or taking AUSTEDOTM at 1-800-887-8100. Resources include nursing support, disease education, and financial assistance programs. AUSTEDOTM is expected to be available in the U.S. within the next 3 weeks.
AUSTEDOTM is indicated for the treatment of chorea associated with Huntington’s disease.
The efficacy of AUSTEDOTM as a treatment for chorea associated with Huntington's disease was established in a randomized, double-blind, placebo-controlled, multi-center trial conducted in 90 ambulatory patients with manifest chorea associated with Huntington’s disease. Total Maximal Chorea Scores for patients receiving AUSTEDOTM improved by approximately 4.4 units from baseline to the maintenance period (average of Week 9 and Week 12), compared to approximately 1.9 units in the placebo group. The treatment effect of -2.5 units was statistically significant (p<0.0001). The Maintenance Endpoint is the mean of the Total Maximal Chorea Scores for the Week 9 and Week 12 visits. At the Week 13 follow-up visit (1 week after discontinuation of the study medication), the Total Maximal Chorea Scores of patients who had received AUSTEDOTM returned to baseline.
Important Safety Information
WARNING: DEPRESSION AND SUICIDALITY. AUSTEDOTM can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of AUSTEDOTM must balance the risks of depression and suicidality with the clinical need for treatment of chorea. AUSTEDOTM is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.
AUSTEDOTM is also contraindicated in: patients with hepatic impairment; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; patients taking reserpine or within 20 days of discontinuing reserpine; and patients taking tetrabenazine (XENAZINE®).
VMAT2 inhibitors, including AUSTEDOTM, may cause a worsening in mood, cognition, rigidity, and functional capacity. Neuroleptic Malignant Syndrome has been observed in patients receiving tetrabenazine (a closely related VMAT2 inhibitor). AUSTEDOTM may increase the risk of akathisia, agitation, and restlessness and may cause parkinsonism in patients with Huntington’s disease. Sedation is a common dose-limiting adverse reaction of AUSTEDOTM.
Tetrabenazine causes an increase in the corrected QT (QTc) interval. A clinically relevant QT prolongation may occur in some patients treated with AUSTEDOTM who are CYP2D6 poor metabolizers or are co-administered a strong CYP2D6 inhibitor. Tetrabenazine elevates serum prolactin concentrations in humans.
Since deutetrabenazine or its metabolites bind to melanin-containing tissues, it could accumulate in these tissues over time. The most common adverse reactions (>8% of AUSTEDOTM-treated patients and greater than placebo) in a controlled clinical study were: somnolence, diarrhea, dry mouth, and fatigue.
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Cautionary Statements Regarding Forward-Looking Information:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
and other factors discussed in our Annual Report on Form 20-F for the