Teva Announces AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets Now U.S. FDA Approved as a One Pill, Once-Daily Treatment Option for Clinically Therapeutic Doses (24–48 mg/day)
Teva Pharmaceuticals announced that the U.S. FDA has approved AUSTEDO XR, an extended-release, once-daily tablet for treating tardive dyskinesia (TD) and Huntington’s disease (HD) chorea, available in four dosages (30, 36, 42, 48 mg). This approval offers flexibility and convenience for patients, with symptom improvement expected as early as two weeks for TD and significant reduction in chorea symptoms for HD. AUSTEDO XR is the only VMAT2 inhibitor without restrictions for use with CYP3A4/5 inducers or inhibitors. Over 90% of patients with insurance coverage will pay $10 or less for their prescription with financial assistance.
- FDA approval of AUSTEDO XR for TD and HD chorea offers a new treatment option.
- Symptom improvement for TD can occur as early as two weeks.
- HD chorea patients may see a significant reduction in Total Maximal Chorea (TMC) score.
- AUSTEDO XR provides the most once-daily doses for VMAT2 inhibitors.
- No restrictions for use with CYP3A4/5 inducers or inhibitors.
- 90% of patients with insurance coverage expected to pay $10 or less with financial assistance.
- Potential risk of side effects not detailed in the press release.
- Financial burden on patients without insurance coverage remains unclear.
- Increased competition from other TD and HD treatments could impact market share.
- Uncertain long-term efficacy and side effects beyond three years of study data.
Insights
AUSTEDO XR's FDA approval for once-daily administration is a notable advancement for patients with tardive dyskinesia (TD) and Huntington's disease (HD) chorea. This new formulation simplifies the treatment regimen, making it easier for patients to adhere to their medication schedule. Given that TD and HD chorea are chronic conditions, a once-daily pill could significantly improve the quality of life for patients by reducing the burden of managing multiple doses.
The clinical outcomes highlighted, such as symptom improvement in as early as two weeks for TD patients and significant reductions in Total Maximal Chorea (TMC) score for HD patients, add weight to the drug’s efficacy. The longer three-year clinical trial results provide robust data that should instill confidence in both physicians and patients regarding the drug's safety and effectiveness.
For retail investors, the approval not only underlines the drug’s therapeutic value but also positions Teva Pharmaceuticals as a key player in the treatment of movement disorders. However, investors should consider the competitive landscape of VMAT2 inhibitors and the potential for other pharmaceutical companies to introduce similar or improved treatments over time.
From a financial perspective, Teva’s FDA approval of AUSTEDO XR is likely to have a positive impact on the company's revenue stream. Simplifying the dosing regimen to a once-daily pill can enhance patient compliance, potentially increasing the market uptake of AUSTEDO XR.
With approximately 90% of patients expected to pay $10 or less due to insurance coverage and financial assistance, Teva is clearly aiming to maximize accessibility, which can drive higher prescription volumes. Investors should note that financial assistance and low out-of-pocket costs are strategic moves to capture a larger market share, even if it may slightly erode near-term profit margins.
Furthermore, Teva’s continued support with access, reimbursement and patient assistance programs shows a commitment to patient-centric care, which may bolster the company's reputation and lead to long-term financial gains. However, investors must be cautious of potential pricing pressures and reimbursement challenges in the highly regulated pharmaceutical market.
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U.S. FDA approves new one pill, once-daily AUSTEDO XR tablets (30, 36, 42, 48 mg/day) - AUSTEDO XR offers more flexibility with the most once-daily doses of any vesicular monoamine transporter 2 (VMAT2) inhibitor for effective and tolerable tardive dyskinesia (TD) and Huntington’s disease (HD) chorea control1
- Patients with TD taking AUSTEDO XR can expect symptom improvement as early as two weeks while patients with HD chorea may experience a significant reduction in Total Maximal Chorea (TMC) score, with three years of the longest TD and HD chorea clinical trials and sustained results to date 1,2,3,4,5
“Since our launch of AUSTEDO® in 2017, we have been committed to helping people living with TD and HD chorea treat these chronic, involuntary movements,” said Dell Faulkingham, Senior Vice President, Head of
Currently more than 57 million Americans are living with a mental illness, 14 million of whom are living with a serious mental health condition.6 For those taking certain mental health medications, one in four may experience the onset of TD, an often-overlooked chronic movement disorder that can have a physical, emotional and psychological impact on patients.7,8 HD is a fatal neurodegenerative disease characterized by cognitive deterioration, behavior and/or psychological problems and uncoordinated and uncontrollable movements known as chorea – a symptom that affects
“Knowing patients living with TD and HD chorea are also managing other underlying concomitant conditions, it is important that treatment options for these chronic movement disorders are not only effective, but keep the patient experience in mind,” said Dr. Rakesh Jain, Clinical Professor of Psychiatry, Texas Tech University School of Medicine. “This latest AUSTEDO XR approval provides patients with the same proven efficacy, but now with the convenience of a one pill, once-daily option for clinically therapeutic doses as established by the pivotal clinical trials to help control involuntary movements that can make carrying out basic daily activities difficult."
Patients with TD taking AUSTEDO XR can expect symptom improvement as early as two weeks while patients with HD chorea may experience a significant reduction in TMC score, with three years of the longest TD and HD chorea clinical trials and sustained results to date.1,2,3,4,5 AUSTEDO XR, along with its twice-daily counterpart, AUSTEDO (deutetrabenazine), are the only VMAT2 inhibitor treatments with no restrictions for use with CYP3A4/5 inducers or inhibitors, an important consideration for patients who take a variety of concomitant medications to manage their underlying conditions.11,12
Approximately
About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD) is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals. 13,14,15
About Chorea Associated with Huntington’s Disease (HD)
Huntington’s disease (HD) is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems. Chorea – involuntary, random and sudden, twisting and/or writhing movements – is one of the most striking physical manifestations of Huntington’s disease and occurs in approximately
About AUSTEDO XR Extended-Release Tablets and AUSTEDO Tablets
AUSTEDO XR and AUSTEDO are the first vesicular monoamine transporter 2 (VMAT2) inhibitors approved by the
INDICATIONS AND USAGE
AUSTEDO XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.
IMPORTANT SAFETY INFORMATION
Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.
Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine.
Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects.
QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.
Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.
Akathisia, Agitation, and Restlessness: AUSTEDO XR and AUSTEDO may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.
Parkinsonism: AUSTEDO XR and AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.
Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.
Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO XR and AUSTEDO.
Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.
Common Adverse Reactions: The most common adverse reactions for AUSTEDO (>
Please see accompanying full Prescribing Information, including Boxed Warning.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
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. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize AUSTEDO and AUSTEDO XR for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2024 and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
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1 Data on file.
2 Hauser, R. A., Barkay, H., Fernandez, H. H. et al. Long-Term Deutetrabenazine Treatment for Tardive Dyskinesia is Associated with Sustained Benefits and Safety: A 3-Year, Open-Label Extension Study. Frontiers in Neurology (2022). https://doi.org/10.3389/fneur.2022.773999.
3 Anderson K. E., Stamler D., Davis M. D., et al. Deutetrabenazine for the treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomized, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604
4 Fernandez HH, Factor SA, Hauser RA, et al. Randomised controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study. Neurology. 2017;88(21):2003-2010.
5 Marder S. R., Singer C., Lindenmayer J-P., et al. A phase 3, 1-year, open-label trial of valbenazine in adults with tardive dyskinesia. J Clin Psychopharmacol. 2019;39(6)620-627.
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7 Carbon M, Hsieh CH, Kane JM, Correll CU. Tardive dyskinesia prevalence in the period of second-generation antipsychotic use: a meta-analysis. J Clin Psychiatry. 2017;78(3):e264-e278.
8 Hansen TE, Brown WL, Weigel RM, Casey DE. Underrecognition of tardive dyskinesia and drug-induced parkinsonism by psychiatric residents. Gen Hosp Psychiatry. 1992;14(5):340-344.
9 Huntington’s Disease. National Institute of Neurological Disorders and Stroke. https://www.ninds.nih.gov/health-information/disorders/huntingtons-disease#toc-what-is-huntington-s-disease-. Accessed May 15, 2023.
10 Thorley, E. M., Iyer, R. G., Wicks, P., Curran, C., Gandhi, S. K., Abler, V., Anderson, K. E., & Carlozzi, N. E. (2018). Understanding How Chorea Affects Health-Related Quality of Life in Huntington Disease: An Online Survey of Patients and Caregivers in
11 AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets [current approved prescribing information].Parsippany, NJ: Teva Neuroscience, Inc
12 AUSTEDO® (deutetrabenazine) tablets current Prescribing Information.
13 Warikoo N, Schwartz T, Citrome L. Tardive dyskinesia. In: Schwartz TL, Megna J, Topel ME, eds. Antipsychotic Drugs.
14 Waln O, Jankovic J. An Update on Tardive Dyskinesia: From Phenomenology to Treatment. Tremor Other Hyperkinet Mov. 2013;3:1-11.
15 Tardive dyskinesia. National Alliance on Mental Illness website. https://www.nami.org/Learn-More/Treatment/Mental-Health-Medications/Tardive-Dyskinesia. Accessed May 15, 2023.
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FAQ
What is the new treatment option for TD and HD chorea approved by the FDA?
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How does AUSTEDO XR benefit patients financially?
