19 presentations will examine long-term and real-world AJOVY data as well as AUSTEDO safety and adherence data
TEL AVIV, Israel & PARSIPPANY, N.J.–(BUSINESS WIRE)–Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced 19 presentations examining clinical and real-world data for AJOVY® (fremanezumab-vfrm) injection and AUSTEDO® (deutetrabenazine) tablets will be presented at the upcoming 2021 American Academy of Neurology (AAN) Virtual Annual Meeting, taking place April 17-22.
“We are committed to improving the lives of patients and further evaluating AJOVY and AUSTEDO so we can continue to help healthcare professionals and patients make informed treatment decisions,” said Denisa Hurtukova, MD, VP, Head of North America Medical Affairs. “The data being presented at this year’s AAN meeting offer important information on the integrated safety of AUSTEDO as well as clinical analyses and real-world experience of patients treated with AJOVY.”
At this year’s AAN, Teva’s neurology portfolio will highlight integrated safety data for AUSTEDO in the treatment of both tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). The analysis examined safety by comparing the incidence of adverse events with AUSTEDO versus placebo in: two pivotal TD studies (ARM-TD and AIM-TD) and through week 15 of an open-label extension study (RIM-TD); as well as data in HD patients captured upon first exposure to AUSTEDO in the First-HD pivotal trial and through week 15 of a long-term open label extension trial (ARC-HD).
Other AUSTEDO posters include an analysis of real-world adherence patterns with AUSTEDO and tetrabenazine among patients diagnosed with HD, as well as the impact on quality of life of different severity levels of chorea associated with HD.
AJOVYdata being presented include results from clinical and real-world analyses. The data being presented at the meeting spans 17 posters and include post-hoc Phase 3 data examining the long-term response of AJOVY in patients who initially did not respond to treatment, an analysis of real-world treatment patterns for patients prescribed AJOVY, and a retrospective evaluation of quarterly and monthly dosing with AJOVY in a real-world setting.
This year’s annual AAN meeting is fully virtual. Data presentations can be accessed by registering for the meeting.
The full set of Teva-sponsored neurology portfolio data to be presented includes:
- P10.023 Long-term Efficacy of Fremanezumab in Patients with Chronic or Episodic Migraine Who Were Inadequate Responders to Initial Fremanezumab Treatment
- P10.031 US Real-world Effectiveness of Quarterly and Monthly Fremanezumab for Reducing Migraine Days and Headache Days in Adult Patients with Migraine
- P10.088 US Real-World Patient Characteristics, Acute Medication Use, and Treatment Patterns for Patients Initiating Fremanezumab
- P10.021 Early Reductions in Headache Severity and Duration With Fremanezumab Treatment in the Randomized, Double-blind Phase 3b FOCUS study
- P10.125 Effect of Fremanezumab on the Total Burden of Migraine in Patients with Episodic or Chronic Migraine: Findings from 3 Randomized, Double-blind, Placebo-controlled Phase 3 Studies
- P10.120 Real-world Reductions in Migraine and Headache Days for Patients With Chronic and Episodic Migraine Initiating Fremanezumab in the US
- P10.051 US Real-world Migraine-related Health Care Resource Utilization and Costs for Patients Initiating Fremanezumab
- P10.122 Baseline Comorbidities and Changes in Acute Medication Use by Quarterly and Monthly Dosing Regimen in Patients Prescribed AJOVY in US Physician Practices
- P10.046 Efficacy of Fremanezumab in Patients With Moderate and Higher Frequency Episodic Migraine
- P10.024 Efficacy of Fremanezumab in Patients With Lower and Higher Frequency Chronic Migraine
- P10.029 A Phase 2 Study of Fremanezumab as a Treatment for Posttraumatic Headache in Adult Patients
- P10.121 Improvements in Patient-reported Migraine Pain Intensity and Composite Migraine Symptoms With Fremanezumab in the Real World
- P10.119 Real-world Adherence, Persistence, Switching, and Reinitiation in Patients Prescribed AJOVY in US Physician Practices
- P10.123 Real-World Adherence, Persistence, Switching, and Reinitiation by Quarterly and Monthly Dosing Regimen in Patients Prescribed AJOVY in US Physician Practices
- P10.118 Number Needed to Treat/Harm for Fremanezumab in Patients Who Had Inadequate Response to 2-4 Prior Migraine Preventive Medication Classes
- P10.034 Cardiovascular Safety of Fremanezumab in Patients With Migraine and Cardiovascular Medical History or Risk Factors: a Pooled Analysis of Phase 3 Studies
- P10.007 Efficacy in Patients Switching from Quarterly to Monthly Fremanezumab or Maintained on Monthly Fremanezumab Treatment Over 6 Months in the Phase 3b FOCUS Study
- P14.136 Incidence of Adverse Events Associated With Deutetrabenazine for the Treatment of Tardive Dyskinesia and Chorea Associated With Huntington’s Disease
Encore health economic data:
- P14.047 Real-World Adherence to Tetrabenazine or Deutetrabenazine Among Patients With Huntington’s Disease
- P14.044 Defining Utility Values for Chorea Health States in Patients With Huntington’s Disease
About AJOVY® (fremanezumab-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 monthly administered 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.
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 a vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of tardive dyskinesia in adults and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established.
Indications and Usage
AUSTEDO® is indicated for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia in adults.
Important Safety Information
Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDOcan 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: AUSTEDOmay 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 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 regarding AJOVY and AUSTEDO, 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:
- the commercial success of AJOVY;
- the commercial success of AUSTEDO;
- our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; delays in launches of new generic products; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; 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, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
- our business and operations in general, including: uncertainty regarding the magnitude, duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; 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; effectiveness of our optimization efforts; our ability to attract, hire and retain highly skilled personnel; manufacturing or quality control problems; interruptions in our supply chain; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism; 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; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets;
- compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; increased legal and regulatory action in connection with public concern over the abuse of opioid medications and our ability to reach a final resolution of the remaining opioid-related litigation; scrutiny from competition and pricing authorities around the world, including our ability to successfully defend against the U.S. Department of Justice criminal charges of Sherman Act violations; potential liability for patent infringement; product liability claims; failure to comply with complex Medicare and Medicaid reporting and payment obligations; compliance with anti-corruption sanctions and trade control laws; and environmental risks;
- other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;
and other factors discussed in this press release and in our Annual Report on Form 10-K for the year ended December 31, 2020, including in the sections captioned “Risk Factors” and “Forward Looking Statements.” 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.
Kevin C. Mannix (215) 591-8912
Yael Ashman 972 (3) 914-8262
Doris Li (973) 265-3752
Yonatan Beker 972 (54) 888 5898