טבע תציג ניתוחים חדשים של יעילות ובטיחות Fremanezumab בחולים בוגרים עם מיגרנה קשה לטיפול בקונגרס ה -19 של האגודה הבינלאומית לכאבי ראש

נתונים חדשים בוחנים את יעילות העלות של fremanezumab במשך 10 שנים, ואילו מצגת אחת ו -29 פוסטרים מדגישים את נתוני המחקר FOCUS בשלב IIIb בקרב חולים בוגרים עם מיגרנה, עם תגובה מתועדת בלתי מספקת ל- 2-4 סוגים של טיפולים מונעים קודמים, יחד עם תוצאות סקר מטופלים ותוצאות יעילות לאחר מעשה לאחר המחקר הארוך טווח HALO בשלב III

ירושלים, 3 בספטמבר 2019 - טבע תעשיות פרמצבטיות בע"מ (NYSE ו- TASE: TEVA) הודיעה היום כי החברה תציג יותר מ -30 ניתוחים על fremanezumab, בקונגרס ה -19 של האגודה הבינלאומית לכאב ראש (IHC), המתקיים בדבלין, אירלנד בתאריכים 5-8 בספטמבר 2019. טבע תציג נתונים חדשים המעריכים את יעילות העלות של 10 שנים של ניתוחי fremanezumab וניתוחי פוסט-הוק (לאחר מעשה), כמו גם נתוני נקודת קצה משניים וחקירתיים מהשלב הבינלאומי, הרב-מרכזי, האקראי, מבוקר פלסבו מחקר FOCUSIIIb. מחקר זה העריך את היעילות והבטיחות של טיפול רבעוני וחודשי ב fremanezumab בהשוואה לפלסבו בקרב חולים בוגרים עם מיגרנה ותיעדו תגובה לא מספקת ל 2-4 סוגים של טיפולי מיגרנה קודמים. כמו כן מוצגים חמש פוסטרים המבוססים על סקר מטופלים בעקבות המחקר השנתי HALO שלבIII לטווח ארוך שבדק את ההשפעה של fremanezumab על תפקוד ופרודוקטיביות בקרב חולי מיגרנה. הצגת הנתונים בקונגרס זה באה בעקבות פרסום נתוני המחקר של FOCUS ב- TheLancet בחודש שעבר.

"מיגרנה היא אחת המחלות הנפוצות בעולם, עם למעלה ממיליארד אנשים החיים איתה ברחבי העולם", אמר ג'ושוע מ. כהן, MD, MPH, FAHS, מנהל רפואי מוביל למיגרנה וכאבי ראש בטבע. "אנו מחויבים ללמוד מחלה מכבידה זו ושואפים להוביל את הדרך במחקר מיגרנה. אנו גאים לשתף מגוון רחב של נתונים חדשים של fremanezumab ב- IHC השנה, בין היתר מהמחקר הגדול ביותר עד כה בקרב חולים אשר הגיבו באופן לא מספק ל 2-4 סוגים של טיפולי מיגרנה קודמים."

ניתוחי נתוני ה- FOCUS ב- IHC העריכו את תחילת הפעולה, שימוש יתר בתרופות, דיכאון, איכות חיים והיפוך ממיגרנה כרונית לארעית והמחישו ירידה משמעותית במספר שעות וימים של כאב ראש, וימי מיגרנה, שסבלו מטופלים הקשים לטיפול עם מיגרנה כאשר הם מטופלים עם fremanezumab חודשי או רבעוני, בהשוואה לפלסבו. תופעות הלוואי השכיחות ביותר כללו תגובות באתר ההזרקה. סקר מטופלים שנערך לאחר המחקר השנתי שלב III HALO לטווח הארוך, העריך את שביעות הרצון של המטופלים מטיפול fremanezumab והשפעה על איכות החיים והעדפות המטופלים למשטרי מינון בטיפול המונע במיגרנה.

להלן מבחר תקצירים שנתקבלו להצגה במהלך IHC השנה:

Later Breaking Data:

  • [IHC-LB-006] Burden of comorbid depression and anxiety on migraine-specific health-related quality of life in adult migraine patients in the United States (September 6, 2019, 11 – 12pm IST)
  • [IHC-LB-030] 10-year cost-effectiveness analyses of response-based fremanezumab use in migraine patients with inadequate response to prior preventive treatments (September 6, 2019, 11 – 12pm IST)
  • [IHC-LB-037] 10-year cost-effectiveness analyses of fremanezumab compared to erenumab as preventive treatment in episodic migraine for patients with inadequate response to prior preventive treatments (September 6, 2019, 11 – 12pm IST)
  • [IHC-OR-040] (de novo): Efficacy and safety of fremanezumab for the prevention of episodic cluster headache: results of a randomized, double-blind, placebo-controlled, phase 3 study (September 8, 2019, 8:20am IST)

Oral Presentation:

  • [IHC-OR-012] Very early onset* of action of fremanezumab in patients with migraine and documented inadequate response to 2-4 classes of migraine preventive treatments: results of the international, multicentre, randomised, placebo-controlled FOCUS study (September 7, 2019, 10:30am IST)

Poster Presentations:

  • [IHC-PO-138] Efficacy with fremanezumab in migraine patients with comorbid moderate to severe depression and documented inadequate response to 2-4 classes of migraine preventive treatments: subgroup analysis of the randomised, placebo-controlled FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-137] Early onset* of response to fremanezumab in migraine patients with moderate to severe depression and documented inadequate response to 2-4 classes of migraine preventive treatments: subgroup analysis of the randomised, placebo-controlled FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-156] Efficacy of fremanezumab in migraine patients with medication overuse and documented inadequate response to 2-4 migraine preventive medications: subgroup analysis of the randomised, placebo-controlled FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-148] Impact of fremanezumab on disability in migraine patients with medication overuse and documented inadequate response to 2-4 classes of preventive treatments: subgroup analysis of the randomised, double-blind FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-149] Impact of fremanezumab on migraine-specific quality of life in patients with medication overuse and documented inadequate response to 2-4 classes of migraine preventive treatments: subgroup analysis of the international, multicentre, randomised, double-blind FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-150] Early onset* of efficacy with fremanezumab in patients with medication overuse and documented inadequate response to 2-4 classes of migraine preventive treatments: subgroup analysis of the randomised, double-blind FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-157] Clinically meaningful responses to fremanezumab in migraine patients with medication overuse and documented inadequate response to 2-4 migraine preventive medications in the randomised, placebo-controlled FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-171] A pharmacokinetic bioequivalence study of fremanezumab administered subcutaneously using an autoinjector and a prefilled syringe (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-172] Impact of fremanezumab on any acute headache medication use in migraine patients with medication overuse and documented inadequate response to 2-4 migraine preventive medications in the multicentre, randomised, placebo-controlled FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-151] Reversion from chronic to episodic migraine in patients with documented inadequate response to 2-4 classes of migraine preventive treatments: results of the randomised, placebo-controlled FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-384] Efficacy of fremanezumab in male patients with migraine and documented inadequate response to 2-4 classes of migraine preventive treatments: results of the randomised, placebo-controlled FOCUS study (September 7, 14:45 – 15:45pm IST)
  • [IHC-PO-404] Patient preference and satisfaction following completion of a 1-year extension study (September 7, 14:45 – 15:45pm IST)
  • [IHC-PO-388] Functioning and productivity impact of fremanezumab in migraine patients: a patient survey study following completion of a 1-year extension study (September 7, 14:45 – 15:45pm IST)

*Early onset of efficacy (efficacy measures: reduction in migraine days, reduction in headache days, response rate) is defined as week one following treatment initiation.

About FOCUS

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).

  • 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.

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®q 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

qAdverse 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.

אודות טבע

טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) מפתחת ומייצרת תרופות לשיפור חייהם של אנשים מזה למעלה ממאה שנה. אנו מובילים גלובליים בגנריקה ובתרופות ייחודיות, עם פורטפוליו הכולל יותר מ- 2,400 מוצרים בכמעט כל תחום טיפולי. בכל יום, קרוב ל-200 מיליון אנשים ברחבי העולם נוטלים תרופה של טבע, הודות לאחת ממערכות התפעול הגדולות והמורכבות בתעשייה הפרמצבטית. נוסף על מעמדנו המבוסס בגנריקה, יש לנו פעילות מחקר חדשני משמעותית התומכת בפורטפוליו המוצרים הייחודיים והביופרמצבטיים הגדל שלנו. למידע נוסף על החברה, בקרו באתר www.Teva.co.il

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  • uncertainties relating to the potential benefits and success of our new structure and recent senior management changes as well as the potential success and our ability to effectively execute a restructuring plan;
  • our generics medicines business, including: that we are substantially more dependent on this business, with its significant attendant risks, following our acquisition of Allergan plc’s worldwide generic pharmaceuticals business (“Actavis Generics”); our ability to realize the anticipated benefits of the acquisition (and any delay in realizing those benefits) or difficulties in integrating Actavis Generics; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; price erosion relating to our generic products, both from competing products and as a result of increased governmental pricing pressures; and our ability to take advantage of high-value biosimilar opportunities;
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and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. 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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