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|May 15, 2018 11:05 a.m.|
|Teva Announces Publication of Phase III Trial Data of Fremanezumab for the Preventive Treatment of Episodic Migraine in the Journal of the American Medical Association|
"The results of the HALO study are encouraging and provide insight into the effect of targeting the underlying biological mechanisms of migraine," said
The HALO EM trial met its primary endpoint demonstrating that fremanezumab significantly reduced monthly migraine days for both quarterly and monthly dosing regimens:
The mean change in the Migraine Disability Assessment (MIDAS) score was also measured. The MIDAS questionnaire assesses headache-related disability based on lost days of activity over the previous three months, with scores of 0–5 (little or no disability), 6–10 (mild disability), 11–20 (moderate disability), and ≥21 (severe disability). Baseline mean MIDAS scores were 38.0, 41.7, and 37.3 points in the monthly, quarterly, and placebo groups, respectively. MIDAS scores improved with fremanezumab to 12.6 points for monthly (P < 0.001) and 14.6 points for quarterly (P = 0.002) dosing compared with 19.4 points for placebo. The multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolled 875 patients and consisted of a screening visit, 28-day pre-treatment period, 12-week treatment period, and final evaluation at week 12. The most common adverse events in patients treated with fremanezumab were injection site pain, induration, and erythema.
"With this publication in JAMA, all Phase II and Phase III studies of fremanezumab have now been published in prominent peer-reviewed medical journals which highlights the importance of these data for the migraine community," said
Fremanezumab is an investigational therapy currently under review by the
Fremanezumab is a monoclonal antibody targeting the CGRP (calcitonin gene-related peptide) ligand, currently being investigated as a preventive treatment for migraine. With limited availability of preventive treatment options, fremanezumab represents a potential new option to address a significant unmet medical need.
About the HALO Clinical Research Program
The Phase III HALO EM and CM studies were 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies to compare the safety, tolerability, and efficacy of four dose regimens 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).
Migraine is an unpredictable neurological condition with symptoms such as severe head pain and physical impairment that can impact quality of life and productivity. There are two clinical manifestations of migraine – chronic, where patients suffer 15 or more headache days per month, and episodic, where patients have 14 or less headache days per month. Worldwide, approximately 90% of people diagnosed with migraine have episodic migraine and 10% have chronic migraine.
With more than 1 billion people affected worldwide, migraine is the third most prevalent illness in the world and the 6th most disabling illness in the world. In the U.S., EU5 and
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 Annual Report on Form 10-K for the year ended