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
'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 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
About Teva
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
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