Study evaluated quarterly or monthly dosing for the preventive treatment of migraine
JERUSALEM--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that results from the 52-week, multicenter, randomized, double-blind, parallel group study evaluating monthly or quarterly AJOVY® (fremanezumab-vfrm) injection in adults with chronic migraine (CM) or episodic migraine (EM), were published online ahead of print in Neurology.
“Migraine can be a difficult disease to treat, and is often debilitating for those who suffer from it,” said Denisa Hurtukova, MD, Vice President, Head of North America Medical Affairs, Teva. “We are pleased to publish these results, which add to the growing body of knowledge on AJOVY and give us further insight into the potential for AJOVY to improve clinical outcomes with both quarterly and monthly dosing regimens. These results also underscore Teva’s commitment to patients with migraine and providing potential long-term treatment options for this debilitating disease.”
As the primary purpose of the study was the collection of long-term safety data for patients treated with AJOVY, the study was not placebo-controlled. Patients and investigators were both blinded to the dosing regimen (quarterly vs. monthly) to allow for comparisons between the two dosing options. The study was conducted between March 2016 and December 2018, and included 1890 patients with CM (1,110) and EM (780). Patients who completed either the HALO CM or HALO EM trials had the option to roll over to this long-term study, and new patients could also be enrolled. A total of 312 patients were newly enrolled. Patients were studied at 135 sites, which included clinical research centers, academic medical centers, and neurology/headache practices in the US, Japan, Czech Republic, Russia, Canada, Finland, Poland, Israel, and Spain.
The primary objective of the study was to observe the long-term safety and tolerability of AJOVY over 52 weeks. The most common adverse events (AEs) leading to discontinuation (3-5 percent of patients) included injection site erythema, injection site rash, injection site swelling, injection site pruritis and increased weight. No clinically significant patterns of AEs or serious AEs were seen in the current study. No treatment-emergent, clinically significant laboratory findings were observed.
“Patients with migraine have difficulty remaining on many migraine preventive therapies for prolonged periods and persistence rates at 6 months are known to be quite low, with literature citing lack of efficacy and adverse events as the most common reasons for discontinuation,” said Peter J. Goadsby, MD, PhD, NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK. “The low rates of discontinuation in this 12 month extension study due to lack of efficacy (4 percent of patients) or adverse events (3-5 percent of patients) suggest the potential that patients may be able to persist with this medication over a clinically relevant length of time.”
Although the study was not placebo-controlled, exploratory efficacy evaluations included mean change from baseline in the monthly number of migraine days, headache days of at least moderate severity, headache days of any severity, and days with any acute headache medication use at months three, six, and 12. Additionally, for patients with CM, mean change from baseline in headache-related disability score at months six and 12 was measured by the six-item Headache Impact Test (HIT-6) and for patients with EM, the mean change from baseline in headache-related disability score at months six and 12 was measured by the Migraine Disability Assessment (MIDAS) questionnaire.
In patients with CM or EM, the monthly number of migraine days decreased from baseline to month 12 (CM quarterly, –7.2 days; CM monthly, – 8.0 days; EM quarterly, –5.2 days; EM monthly, –5.1 days). Reductions in monthly number of headache days of at least moderate severity from baseline to month 12 were observed (CM quarterly, –6.4 days; CM monthly, –6.8 days; EM quarterly, –4.4; EM monthly, –4.2 days). Monthly number of headache days of any severity and monthly number of days of any acute headache medication use were also reduced across all treatment groups. More than half of patients with CM and approximately two-thirds of patients with EM had a ≥ 50 percent reduction in monthly average number of migraine days from baseline to month 12. Specifically, the proportions of patients who had a ≥ 50 percent response rate continued to increase over time. Additionally, the degree of headache-related disability decreased for both CM and EM patients from baseline to month 12.
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-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®, 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 quarters 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 (215) 591-8912
Yael Ashman 972 (3) 914-8262
Doris Li (973) 265-3752
Yonatan Beker 972 (54) 888 5898
Source: Teva Pharmaceutical Industries Limited