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Late breaking data examines 10-year cost effectiveness of fremanezumab, while one oral presentation and 29 posters highlight FOCUS Phase IIIb study data in adult patients with migraine and documented inadequate response to 2-4 classes of prior preventive treatments, along with patient survey results and post hoc efficacy results following the 1-year Phase III HALO long-term study
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Company will present more than 30 analyses on fremanezumab, at the 19th Congress of the International Headache Society (IHC), taking place in Dublin, Ireland on September 5-8, 2019. Teva will present late-breaking data evaluating the 10-year cost effectiveness of fremanezumab and post hoc subgroup analyses as well as secondary and exploratory endpoint data from the international, multicentre, randomised, placebo-controlled Phase IIIb FOCUS study. This study evaluated the efficacy and safety of quarterly and monthly treatment with fremanezumab compared to placebo in adult patients with migraine and documented inadequate response to 2-4 classes of prior preventive migraine treatments. Also being presented are five posters based on a patient survey following the one-year Phase III HALO long-term study that examined the impact of fremanezumab on functioning and productivity in migraine patients. The presentation of data at this congress follows the publication of FOCUS study data in The Lancet last month.
“Migraine is one of the most prevalent diseases in the world, with more than 1 billion people living with it globally,”1 said Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine & Headache, Teva. “We are committed to studying this burdensome disease and strive to lead the way in migraine research. We are proud to share a broad range of new fremanezumab data at this year’s IHC from, amongst others, the largest study to date in patients who have responded inadequately to 2-4 classes of prior preventive migraine treatments.”
The FOCUS data analyses at IHC evaluated onset of action, medication overuse, depression, quality of life, and reversion from chronic to episodic migraine, and demonstrated a significant reduction in the number of headache hours and days, and migraine days, suffered by difficult-to-treat patients with migraine when treated with monthly or quarterly fremanezumab, compared to placebo. The most common adverse events included injection site reactions. A patient survey following the one-year Phase III HALO long-term study evaluated patient satisfaction with fremanezumab treatment, and impact on quality of life, and patient preferences for dosing regimens in the preventive treatment of migraine.
Below is a selection of accepted abstracts being presented at IHC 2019:
Later Breaking Data:
*Early onset of efficacy (efficacy measures: reduction in migraine days, reduction in headache days, response rate) is defined as week one following treatment initiation.
The Phase IIIb FOCUS study is a multicentre, randomised, double-blind, parallel-group, placebo-controlled study that evaluated the efficacy, safety, and tolerability of quarterly and monthly treatment with fremanezumab, compared to placebo. Adult patients with chronic migraine or episodic migraine who have responded inadequately to 2-4 classes of prior preventive treatments were enrolled in the study.
Inadequate response is defined as: lack of efficacy after at least three months of therapy at a stable dose; or the patient cannot tolerate the drug; or the drug is contraindicated; or the drug is not suitable for the patient. The classes of prior preventive medications include: beta-blockers, anticonvulsants, tricyclics, calcium channel blockers, angiotensin II receptor antagonists, onabotulinumtoxinA, and valproic acid.
In the study, chronic migraine and episodic migraine patients were randomised in blinded-fashion 1:1:1 into one of three treatment groups – a quarterly dosing regimen, a monthly dosing regimen or matching placebo. An open-label extension of three months (weeks 13-24) followed the placebo-controlled portion of the study.
About the HALO Clinical Research Program
The Phase III HALO EM and CM studies were 16-week, multicentre, randomised, double-blind, placebo-controlled, parallel-group studies to compare the safety, tolerability, and efficacy of four dose regimens (two for EM [quarterly and monthly] and two for CM [quarterly and monthly]), of subcutaneous fremanezumab compared to placebo in adults with episodic and chronic migraine. The studies consisted of a screening visit, a 28-day run-in period, and a 12-week (84-day) treatment period, including a final evaluation at week 12 (end-of-treatment [EOT] visit, four weeks [28 days] after the final dose of study drug).
U.S. Important Safety Information about AJOVY® (fremanezumab)
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.
Information for Europe about AJOVY®■ can be found here.
In the EU, AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month
Adverse events should be reported.
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.
Reporting forms and information can be found at https://www.hpra.ie. Adverse events should also be reported to Teva – please refer to local numbers.
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 2,400 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 fremanezumab, 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:
and other factors discussed in our Quarterly Reports on Form 10-Q for the first and second quarter of 2019 and in our Annual Report on Form 10-K for the year ended December 31, 2018, 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.
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Source: Teva Pharmaceutical Industries Ltd.