טבע מודיעה על הגשת בקשה לרישיון ביולוגי ל- FDA עבור Fremanezumab
אבן דרך מרכזית זו הושגה על ידי טבע כחלק מהתכנית הגלובלית של fremanezumab לטיפול מניעתי למיגרנה
Fremanezumab מכוונת לענות על צורך עבור קהילת המיגרנה, מחלה עם טיפולי מניעה זמינים מוגבלים
ירושלים, 17 באוקטובר 2017 – טבע תעשיות פרמצבטיות בע"מ (NYSE ו-TASE: TEVA) הודיעה היום על הגשת בקשה לרישיון ביולוגי (BLA) למינהל המזון והתרופות האמריקאי (FDA) עבור fremanezumab, נוגדן חד שבטי הנקשר לקלציטונין פפטיד של הגן (anti-CGRP) לטיפול למניעת מיגרנה.
"המחקרים הקליניים בשלב 3 של fremanezumab הציגו הפחתה משמעותית במספר ימי המיגרנה, כאב הראש, שימוש בתרופות חריפות ומוגבלויות, בנוסף להדגמת שיפור באיכות חיי המטופלים החיים עם מיגרנה כרונית וארעית", אמר ד"ר ארנסטו אייקרדי, סמנכ"ל וראש תחום טיפולי של מיגרנה וכאבי ראש בטבע. "אנחנו מאוד שמחים על כך שהגשנו את הבקשה לרישיון ביולוגי ל-FDA, צעד חשוב לקראת הבאת טיפול חדש אשר עשוי לסייע להתמודד עם צורך משמעותי של קהילת המיגרנה בקבלת אפשרויות טיפול מניעתי ממוקד".
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).
- In the EM study, 875 patients were enrolled (294, 291, 290 patients in the placebo, quarterly, and monthly dose groups, respectively). Patients were randomized 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 randomized (around 376 patients per treatment group). Patients were randomized 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.
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