Teva to Present New Data on Once-Daily AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets at the 2023 American Academy of Neurology Annual Meeting

Rhea-AI Summary

Teva Pharmaceuticals announced the FDA approval of AUSTEDO XR (deutetrabenazine) once-daily extended-release tablets on February 17, 2023. AUSTEDO XR is therapeutically equivalent to the existing twice-daily AUSTEDO tablets for adults with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). This new formulation is expected to be available commercially later this year. Teva will present data supporting AUSTEDO XR's approval at the American Academy of Neurology (AAN) Annual Meeting on April 22-27, 2023, demonstrating bioequivalence and safety across various dose strengths (6 mg, 12 mg, and 24 mg). Teva's research highlights the improved therapeutic options for patients living with TD and HD chorea.

• Dose proportionality and bioequivalence studies demonstrate once-daily AUSTEDO XR is therapeutically equivalent to twice-daily AUSTEDO^® (deutetrabenazine) tablets
• The U.S. Food and Drug Administration (FDA) approved once-daily AUSTEDO XR extended-release tablets on February 17, 2023
• AUSTEDO is the only vesicular monoamine transporter 2 (VMAT2) inhibitor approved for both tardive dyskinesia and chorea associated with Huntington’s disease indications in adults with 3-year long-term data^1,2

TEL AVIV, Israel & PARSIPPANY, N.J.--(BUSINESS WIRE)-- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced six poster abstracts across its neurology portfolio will be presented at the American Academy of Neurology (AAN) Annual Meeting on April 22-27, 2023. Abstracts include data for AUSTEDO (deutetrabenazine) tablets, as well as once-daily AUSTEDO XR (deutetrabenazine) extended-release tablets. AUSTEDO XR was recently approved by the FDA, as a once-daily formulation of AUSTEDO for adults living with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD), which can be taken with or without food. It is expected to be commercially available later this year.

“Much of the data we’re presenting served as a foundation for the FDA’s recent approval of AUSTEDO XR,” said Eric Hughes, MD, PhD, Executive Vice President of R&D and Chief Medical Officer at Teva. “We’re excited clinicians will have the opportunity to better understand the potential of AUSTEDO XR as a once-daily option that can deliver the same therapeutic benefit as twice-daily AUSTEDO for adults living with TD and HD chorea.”

Notably, these presentations include new data from dose proportionality and bioequivalence studies, which supported the FDA approval of once-daily AUSTEDO XR extended-release tablets – demonstrating AUSTEDO XR is therapeutically equivalent to the currently marketed twice-daily AUSTEDO. Bioequivalence and relative bioavailability were established between the once-daily and twice-daily tablet formulations, with no new safety findings emerging. Additionally, dose proportional exposures were achieved for 6 mg, 12 mg and 24 mg deutetrabenazine dose strengths and AUSTEDO XR may be used across the full clinical dose range (6 mg – 48 mg).

Teva will also present real-world data showing people living with HD chorea who are taking antipsychotic medications with twice-daily AUSTEDO experienced improved motor signs. Additional abstracts from the Enroll-HD Global Registry and AJOVY^® (fremanezumab-vfrm) will also be presented.

This year’s annual AAN meeting is being offered both in person and virtually. Abstracts can be accessed here.

The full set of data sponsored by Teva includes:

Poster Session 1: Sunday, April 23, 8:00 AM - 9:00 AM ET

Enroll-HD Global Registry:

• (Encore) Chorea Severity Change Over Time in Huntington Disease and by Huntington Disease Stage (P1.010)
• (De novo) The Risk of Depression in a Large Huntington Disease Population Compared With Controls: Analysis of the Enroll-HD Registry Data (P1.012)

Poster Session 2: Sunday April 23, 11:45 AM - 12:15 PM ET

AUSTEDO XR:

• (De novo) A Bioequivalence Comparison at Steady State between the Newly Developed Once-Daily Extended Release Tablet Formulation and the Approved Twice-Daily Tablet Formulation of Deutetrabenazine (P2.015)
• (De novo) Assessment of Dose Proportionality of Three Dose Strengths (6 mg, 12 mg and 24 mg) over the Clinical Dose Range (6-48 mg) of the Newly Developed Once-Daily Extended Release Tablet Formulation of Deutetrabenazine (P2.016)

AUSTEDO:

• (Encore) Real-World Effectiveness and Safety of Deutetrabenazine in Combination with Antipsychotic Drugs in Patients With Chorea Associated With Huntington Disease (P2.010)

Enroll-HD Global Registry:

• (Encore) Baseline Characteristics and Treatment Patterns of a Global Huntington Disease Population Stratified by Chorea Severity (P2.011)

Poster Session 10: Wednesday April 26, 8:00 AM – 9:00 AM ET

AJOVY:

• (De novo): Initiation of Fremanezumab Earlier in the Treatment Cycle may Result in Cost Savings to Payors in the United States (P10.002)

Poster Session 12: Wednesday April 26, 5:30 PM – 6:30 PM ET

AJOVY:

• (Encore) Effectiveness of Fremanezumab for the Preventive Treatment of Migraine: Second Interim Analysis of the Observational PEARL Study (P12.002)
• (De novo): No “Wearing-Off Effect” Seen with Fremanezumab in the Real-World: Retrospective, Claims-Based Analysis of Migraine-Related HealthCare Resource and Acute Medication Use (P12.005)

Poster Session 13: Thursday, April 27, 8:00 AM – 9:00 AM ET

AJOVY:

• (Encore) Real-World Effectiveness of Fremanezumab in Patients with Migraine who Switched from another Mab Targeting the CGRP Pathway (P13.007)
• (Encore) Fremanezumab for Migraine Prevention: Interim Analysis of the Non-Interventional FINESSE Study (P13.010)

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.

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 90% of patients. Chorea can have a significant impact on daily activities and progressively limit peoples’ lives.

About AUSTEDO XR Extended-Release Tablets and AUSTEDO Tablets

AUSTEDO is the first and only vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. AUSTEDO XR is the once-daily formulation of AUSTEDO. Safety and effectiveness in pediatric patients have not been established.

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 (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia. Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets.

Please see accompanying full Prescribing Information, including Boxed Warning.

About AJOVY (fremanezumab-vfrm) injection

AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections.

AJOVY can be administered either by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment.

INDICATION
AJOVY is indicated for the preventive treatment of migraine in adults.
Please see full Prescribing Information for AJOVY.

IMPORTANT SAFETY INFORMATION

Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

Adverse Reactions: The most common adverse reactions in clinical trials (≥5% and greater than placebo) were injection site reactions.

Information for Europe about AJOVY can be found here.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events. Information can be found at https://www.hpra.ie.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products. Learn more at 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 the development and commercial success of AUSTEDO (deutetrabenazine) tablets and AUSTEDO XR (deutetrabenazine) extended-release tablets; the development and commercial success of AJOVY; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our innovative medicines, including AUSTEDO, AJOVY and COPAXONE^®, our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2022, 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.

¹ 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.
² Frank, S., Testa, C., Edmondson, M.C. et al. The Safety of Deutetrabenazine for Chorea in Huntington Disease: An Open-Label Extension Study. CNS Drugs (2022). https://doi.org/10.1007/s40263-022-00956-8.

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IR Contacts

United States

Ran Meir (267) 468-4475

Yael Ashman 972 (3) 914-8262

PR Contacts

United States

Doris Yiu (973) 265-3752

Yonatan Beker (973) 917-0851

Source: Teva Pharmaceutical Industries Limited

FAQ

What is AUSTEDO XR approved for?

AUSTEDO XR is approved for the treatment of tardive dyskinesia and chorea associated with Huntington's disease in adults.

When was AUSTEDO XR approved by the FDA?

AUSTEDO XR was approved by the FDA on February 17, 2023.

What are the dosing options for AUSTEDO XR?

AUSTEDO XR is a once-daily formulation, and it is therapeutically equivalent to the twice-daily AUSTEDO.

When will AUSTEDO XR be commercially available?

AUSTEDO XR is expected to be commercially available later in 2023.

What studies support AUSTEDO XR's FDA approval?

The FDA approval of AUSTEDO XR is supported by bioequivalence and dose proportionality studies demonstrating its therapeutic equivalence to twice-daily AUSTEDO.

When will Teva present data on AUSTEDO XR?

Teva will present data on AUSTEDO XR at the American Academy of Neurology Annual Meeting from April 22-27, 2023.