'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
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
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).
In the EM study, 875 patients were enrolled (294, 291, 290 patients in the placebo, quarterly, and monthly dose groups, respectively). Patients were randomised in a 1:1:1 ratio to receive subcutaneous injections of fremanezumab at 225 mg for three months (monthly dose regimen), fremanezumab at 675 mg at initiation followed by placebo for two months (quarterly dose regimen), or three monthly doses of matching placebo. The primary efficacy endpoint of the EM study was the mean change from baseline (28-day run-in period) in the monthly average number of migraine days during the 12-week period after the first dose of fremanezumab.
In the CM study, 1,130 patients were randomised (375, 376, 379 patients in the placebo, quarterly, and monthly groups, respectively). Patients were randomised in a 1:1:1 ratio to receive subcutaneous injections of fremanezumab at 675 mg at initiation followed by monthly 225 mg for two months (monthly dose regimen), fremanezumab at 675 mg at initiation followed by placebo for two months (quarterly dose regimen), or three monthly doses of matching placebo. The primary efficacy endpoint of the CM study was the mean change from baseline (28-day run-in period) in the monthly average number of headache days of at least moderate severity during the 12-week period after the first dose of 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.
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, 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; 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 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; 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; effectiveness of our restructuring plan announced in
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