16 presentations will examine safety and efficacy of AJOVY and AUSTEDO
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new data for two of the company’s neurology portfolio treatments, AJOVY® (fremanezumab-vfrm) injection and AUSTEDO® (deutetrabenazine) tablets. These data will be presented at the American Academy of Neurology (AAN) Annual Meeting on April 2-7, 2022 in person and virtually on April 24-26, 2022.
“Our commitment to improving the lives of patients suffering from migraine and movement disorders is paramount, which is why we are proud to add to the growing body of evidence supporting the safety and efficacy of AJOVY and AUSTEDO across different patient populations and subgroups, in addition to findings on migraine-related healthcare resource utilization costs,” said Denisa Hurtukova, MD, VP, Head of North America Medical Affairs. “We look forward to gathering in person at AAN and continuing to share results from our robust data sets to add to clinicians' understanding of these treatments.”
At this year’s AAN, Teva will highlight safety and efficacy of AJOVY data across populations from different regions and ethnicities, as well as differing disease severity and risk factors. AJOVY data presented at the meeting spans 11 abstracts, including a 6-month safety and efficacy pooled analysis from the Phase 3 FOCUS and HALO studies, and an analysis on efficacy and disability outcomes in patients treated with AJOVY with prior onabotulinumtoxinA treatment failure. Real-world data will be presented regarding reductions in acute medication use for migraine patients initiating AJOVY, as well as a study evaluating healthcare resource use of patients initiating AJOVY.
Teva will also highlight long-term post hoc analyses in patients with tardive dyskinesia (TD) treated with AUSTEDO from the 3-year open label RIM-TD study, examining safety and efficacy outcomes by underlying comorbid psychiatric illness or mood disorder, dopamine-receptor antagonist (DRA) use and dose patterns by TD severity. Additional abstracts include a survey of patients and caregivers in the U.S. examining the burden of TD on patients’ physical, psychological and social well-being, as well as a sentiment analysis of unstructured electronic medical records (EMR) data of patients with Huntington’s disease (HD) or TD.
This year’s annual AAN meeting is being offered both fully in person and virtually. Data presentations can be accessed by registering for the meeting.
The full set of data sponsored by Teva includes:
- Six-Month Safety and Efficacy of Fremanezumab in Migraine: Pooled Analysis from the Phase 3 FOCUS and HALO Studies (S31.007)
- Efficacy and Disability Outcomes of Fremanezumab in Patients With Prior OnabotulinumtoxinA Treatment Failure: Pooled Results of 3 Randomized, Double-Blind, Placebo-Controlled Phase 3 Studies (P3.004)
- Reductions in Acute Medication Use for Patients with Migraine Initiating Fremanezumab: Results of a Long-Term US Claims Database Analysis (P16.005)
- Reductions in Migraine-Related Health Care Resource Utilization and Costs for Patients Initiating Fremanezumab: Results of a Long-Term US Claims Database Analysis (P12.002)
- Direct Health Care Costs of Patients Suffering With Migraine in Southern Israel: a Retrospective Database Analysis (P17.006)
- Timing and Location of Injection-Site Adverse Events With Fremanezumab in Patients with Migraine: A Pooled Analysis of Phase 3 Studies (P16.003)
- Changes in Heart Rate and Blood Pressure in Participants Treated With Fremanezumab for Migraine: A Pooled Analysis of Phase 3 Studies (P3.003)
- Migraine Epidemiology in Southern Israel: A Retrospective Database Study (P17.004)
- Prescription Opioids in Patients With Migraine in Southern Israel: a Retrospective Database Analysis (P17.001)
- Fremanezumab for Preventive Treatment in Migraine: The FINESSE Study (P16.001)
- Safety and Efficacy of Fremanezumab in Different Racial and Ethnic Subgroups of Patients With Migraine: A Pooled Analysis of Phase 3 Studies (P1.004)
- Sentiment Analysis of Unstructured Electronic Medical Record Data of Patients Treated With Vesicular Monoamine Transporter 2 Inhibitors in Huntington’s Disease and Tardive Dyskinesia (P3.006)
- Dose Patterns for Long-Term Deutetrabenazine Treatment in Patients With Tardive Dyskinesia by Baseline Abnormal Involuntary Movement Scale Item 8 Score (P9.001)
- Effects of Long-Term Deutetrabenazine Treatment in Patients With Tardive Dyskinesia and Underlying Psychiatric or Mood Disorders (P9.002)
- Long-Term Efficacy and Safety of Deutetrabenazine in Patients With Tardive Dyskinesia by Concomitant Dopamine-Receptor Antagonist Use (P6.001)
- Impact of Tardive Dyskinesia on Physical, Psychological, and Social Aspects of Patient Lives: A Survey of Patients and Caregivers in the United States (P6.005)
About AJOVY (fremanezumanb-vfrm) Injection
AJOVY is available as a 225 mg/1.5 mL single dose injection in a prefilled syringe or autoinjector with two dosing options – 225 mg administered monthly as one subcutaneous injection, or 675 mg every three months (quarterly), which is administered as three subcutaneous injections. AJOVY can be administered in office by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment. AJOVY is now approved in 45 countries worldwide.
Indications and Usage
AJOVY is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.
U.S. Important Safety Information about AJOVY (fremanezumab-vfrm) injection
Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients.
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. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.
Adverse Reactions: The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.
Please click here for full U.S. Prescribing Information for AJOVY (fremanezumab-vfrm) injection.
About AUSTEDO (deutetrabenazine) 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. TD is a movement disorder that 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. Safety and effectiveness in pediatric patients have not been established.
Indications and Usage
AUSTEDO (deutetrabenazine) tablets is 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 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 is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.
Contraindications: AUSTEDO is contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO is 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 (Xenazine®) or valbenazine (Ingrezza®).
Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects.
QTc Prolongation: AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO is administered within the recommended dosage range. 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; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.
Akathisia, Agitation, and Restlessness: 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 dose should be reduced; some patients may require discontinuation of therapy.
Parkinsonism: 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 dose should be reduced; some patients may require discontinuation of therapy.
Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of 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 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.
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.
Please see accompanying full Prescribing Information, including Boxed Warning.
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, biosimilar and specialty 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 specialty 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: our ability to successfully commercialize AJOVY and AUSTEDO; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our specialty products, 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 uncertainty regarding the COVID-19 pandemic and the governmental and societal responses thereto, our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith, costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; 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, 2021, 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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