טבע מודיעה על השקת הגרסה הגנרית של טבליות Tracleer® (bosentan) בארה"ב
ירושלים, 19 ביוני 2019 – טבע תעשיות פרמצבטיות בע"מ (NYSE and TASE: TEVA) הודיעה היום על השקת הגרסה הגנרית של טבליות ®Tracleer ו62.5 ו-125 מ"ג בארה"ב.
Bosentan Tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1) in adults to improve exercise ability and to decrease worsening of the condition. PAH is high blood pressure in the blood vessels of the lungs. Due to the risks of liver damage, and serious birth defects, Bosentan Tablets are available only through a restricted distribution program called the Bosentan REMS Program.
"השקת טבליות Bosentan בארה"ב מהווה תוספת חשובה לפורטפוליו הגנרי של טבע", אמר ברנדן אוג'ריידי, סמנכ"ל בכיר, מנהל החטיבה המסחרית בצפון אמריקה. "הסיבה המדויקת ליתר לחץ דם ריאתי (PAH) בבוגרים לא ידועה, והוא ללא מרפא מוכר. אנו גאים לספק עוד אופציה טיפולית למטופלים החיים עם מחלה כרונית זו".
עם קרוב ל-500 תרופות גנריות זמינות, לטבע יש את פורטפוליו המוצרים הגנריים מאושרי FDA הגדול בשוק ומובילה בהזדמנויות השקה בבלעדיות (first to file), עם יותר מ-100 תיקי first to file תלויים ועומדים בארה"ב. כיום, 1 מכל 9 מרשמים גנריים הניתנים בארה"ב הוא למוצר של טבע.
About Bosentan Tablets
Bosentan Tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%).
Important Safety Information
WARNING: Risks of Hepatotoxicty and Embryo-Fetal Toxicity. Because of the risks of hepatotoxicity and birth defects, Bosentan Tablets are available only through a restricted program called the Bosentan REMS Program. Elevations of liver aminotransferases (ALT, AST) and liver failure have been reported with bosentan. Bosentan is likely to cause major birth defects if used by pregnant females based on animal data. Therefore, pregnancy must be excluded before the start of treatment with Bosentan Tablets.
Use of bosentan is contraindicated in females who are or may become pregnant. To prevent pregnancy, females of reproductive potential must use two reliable forms of contraception during treatment and for one month after stopping bosentan. Coadministration of cyclosporine A and bosentan resulted in markedly increased plasma concentrations of bosentan. Therefore, concomitant use of bosentan and cyclosporine A is contraindicated. An increased risk of liver enzyme elevations was observed in patients receiving glyburide concomitantly with bosentan. Therefore coadministration of glyburide and bosentan is contraindicated. Bosentan is contraindicated in patients who are hypersensitive to bosentan or any component of the product. Observed reactions include Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), anaphylaxis, rash, and angioedema.
Peripheral edema is a known clinical consequence of PAH and worsening PAH and is also a known effect of bosentan and other endothelin receptor antagonists. In PAH clinical trials with bosentan, combined adverse events of fluid retention or edema were reported in 1.7% (placebo-corrected) of patients. In addition, there have been numerous postmarketing reports of fluid retention in patients with pulmonary hypertension occurring within weeks after starting bosentan. Patients required intervention with a diuretic, fluid management, or hospitalization for decompensating heart failure. Pulmonary edema could be the possibility of associated pulmonary veno-occlusive disease.
Decreased sperm counts have been observed in patients receiving bosentan. Preclinical data also suggest that bosentan, similar to other endothelin receptor antagonists, may have an adverse effect on spermatogenesis. Treatment with bosentan can cause a dose-related decrease in hemoglobin and hematocrit. There have been postmarketing reports of decreases in hemoglobin concentration and hematocrit that have resulted in anemia requiring transfusion.
In clinical trials, the most common adverse reactions (greater than or equal to 3% and greater than placebo) were respiratory tract infection, headache, edema, chest pain, syncope, flushing, hypotension, sinusitis, arthralgia, abnormal serum aminotransferases, palpitations, and anemia. Respiratory tract infection and anemia occurred at a rate greater than or equal to 3% more than placebo.
For more information, please see accompanying Full Prescribing Information, including the Boxed Warning. A copy may be requested from Teva US Medical Information at 888-TEVA-USA (888-838-2872), firstname.lastname@example.org, or Teva’s Public Relations or Investor Relations contacts.
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