Open-label extension of the FOCUS Phase IIIb study examined changes in quality of life, health status, depressive symptoms and work productivity over 12 weeks
Pooled Phase 3 results examined changes in disability using American Headache Society guidelines
Teva Pharmaceuticals USA, Inc., an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced new data examining quality of life, health status, depressive symptoms, work productivity and activity impairment of patients treated with AJOVY during the 12-week open-label extension of the Phase IIIb FOCUS study. An additional analysis of pooled results from three AJOVY Phase III trials (FOCUS, HALO-Episodic Migraine, HALO-Chronic Migraine) examined headache- and migraine-related disability based on guidelines set forth by the American Headache Society (AHS). The data were presented at the AHS Virtual Annual Scientific Meeting.
"Migraine is more than just a headache and profoundly disrupts all aspects of life, including family life, social interactions and workplace success," said Denisa Hurtukova, MD, Vice President, Head of North America Medical Affairs. "It is critical that we take these aspects into consideration when developing a treatment plan and these new AJOVY data broaden our understanding of overall quality of life. Teva is committed to ongoing evaluations of AJOVY and supports clinically meaningful guidelines set forth by the AHS and other professional organizations."
Quality of Life, Health Status, Depressive Symptoms and Work Productivity in the FOCUS Phase IIIb Open-Label Extension
The FOCUS Phase IIIb open-label extension examined quality of life, health status, depressive symptoms and work productivity observed over an additional 12 weeks of treatment with AJOVY. FOCUS evaluated quarterly and monthly treatment with AJOVY compared to placebo in adult patients with migraine and documented inadequate response to 2-4 classes of prior preventive treatments. All patients completing double-blind treatment entered the 12-week open-label extension and received a monthly dose of AJOVY (225 mg) for three months (n=772).
The following results were observed in quality of life, health status, depressive symptoms, and work productivity based on scores from validated patient-reported questionnaires, including Migraine-Specific Quality of Life (MSQOL), 5-level EuroQol-5 Dimension (EQ-5D-5L), Patient Global Impression of Change (PGIC), 9-item Patient Health Questionnaire (PHQ-9), and Work Productivity and Activity Impairment (WPAI) questionnaire:
- MSQoL quality-of-life domain scores and the EQ-5D-5L health status score at the end of the double-blind period (change from baseline: MSQoL, 11.9 to 17.5 points; EQ-5D-5L, 4.7 to 7.2 points) and through the end of the open-label extension (change from baseline: MSQoL, 18.3 to 24.6 points; EQ-5D-5L, 7.3 to 8.0 points).
- The proportion of patients who experienced a response on the PGIC (rating of moderate to a great deal better) increased from 58% to 64% at the end of the double-blind period to 75% to 77% at the end of the open-label extension.
- Depressive symptom scores (based on the PHQ-9) were reduced by 1.6 to 2.4 points by the end of the open-label extension.
- 14.5% to 20% reductions from baseline were reported in overall health-related work impairment by the end of the open-label extension.
Additionally, the safety and tolerability of AJOVY during this open-label extension was evaluated, with the most common adverse events (AEs) being injection-site reactions, such as injection-site erythema (6%). The reports of AEs leading to discontinuation were <1% and 3% for serious AEs.
Disability Severity According to the AHS Consensus
The AHS Consensus Statement provides guidelines on determining response to CGRP pathway targeted treatments for migraine. As changes in migraine frequency may not adequately assess treatment benefit in all patients, these guidelines recommended specific improvements in disability scores on the MIDAS and HIT-6 that would be considered clinically meaningful and evidence of response to treatment. The disability in patients treated with AJOVY (HIT-6 n=1,958; MIDAS n=1,702) was evaluated using pooled data from the three double-blind Phase III trials.
A post-hoc analysis of the pooled Phase III study data based on guidelines set forth by the Consensus Statement noted AJOVY patients experiencing severe disability due to migraine at baseline achieved the following disability score reductions:
- For patients with a baseline MIDAS score of 11-20, the proportion of patients achieving a 5-point reduction from their baseline score was 71% (quarterly) and 70% (monthly) with AJOVY and 49% with placebo.
- The proportion of patients with a baseline MIDAS score of >20 who achieved a ≥30% reduction in points was 69% (quarterly) and 79% (monthly) with AJOVY and 58% with placebo.
- The proportion of patients achieving a 5-point reduction from baseline in HIT-6 scores was 53% (quarterly) and 55% (monthly) with AJOVY and 39% with placebo.
The complete data sets and full presentations can be accessed through the AHS website.
About AJOVY® (fremanezumab-vfrm) injection
AJOVY is available as a 225 mg/1.5 mL single dose injection in a prefilled syringe 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. The AJOVY autoinjector has been approved by the FDA and is available in the U.S. In addition to the U.S., the AJOVY autoinjector is currently available in Germany and should soon be available in other select European markets.
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.
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® (fremanezumab-vfrm) Injection, 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:
- 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; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions, competing glatiramer acetate products and orally-administered alternatives; the uncertainty of commercial success of AJOVY or AUSTEDO®; competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations and the effectiveness of our patents and other measures to protect our intellectual property rights;
- our business and operations in general, including: 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; interruptions in our supply chain, including due to potential effects of the COVID-19 pandemic on our operations and business in geographic locations impacted by the pandemic and on the business operations of our customers and suppliers; adequacy of and 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; implementation of our restructuring plan announced in December 2017; challenges associated with conducting business globally, including adverse effects of the COVID-19 pandemic, political or economic instability, major hostilities or terrorism; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption sanctions and trade control laws; manufacturing or quality control problems; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; 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; our prospects and opportunities for growth if we sell assets and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
- compliance, regulatory and litigation matters, including: increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject or delays in governmental processing time including due to modified government operations due to the COVID-19 pandemic and effects on product and patent approvals; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; 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 our Quarterly Report on Form 10-Q for the first quarter of 2020 and our Annual Report on Form 10-K for the year ended December 31, 2019, 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
972 (3) 926-7516
972 (54) 888 5898