Us Fda Grants Breakthrough Therapy Designation To Novartisa

Novartis Announced That The Us Food And Drug Administration (Fda) Has Granted Ligelizumab (Qge031) Breakthrough Therapy Designation For The Treatment Of Chronic Spontaneous Urticaria (Csu), Also Known As Chronic Idiopathic Urticaria (Ciu), In Patients Who Have An Inadequate Response To H1-Antihistamine Treatment.Csu Is An Unpredictable And Severe Disease Of The Skin, Affecting 0.5-1% Of The Global Population At Any Time. It Is Characterized By The Development Of Itchy, Painful Wheals (Hives), Swelling (Angioedema), Or Both, Lasting For At Least 6 Weeks And Occurring With No Known Cause3. Csu Can Be Challenging Or Frustrating For Patients Due To The Severity And Unpredictable Nature. It Most Commonly Persists For 1-5 Years, But In Some Cases Even Longer.&Ldquo;Chronic Spontaneous Urticaria Is A Debilitating Disease That May Significantly Impact A Patient&Rsquo;S Life. With So Few Treatment Options Available, Patients Are Looking For More And Better Therapies To Control Their Disease,&Rdquo; Said Angelika Jahreis Md, Phd, Novartis Global Head Development Unit Immunology, Hepatology &Amp; Dermatology. &Ldquo;The Us Fda Breakthrough Therapy Designation Recognizes The Need For A More Effective Treatment For This Unpredictable, Systemic And Debilitating Disease.&Rdquo;Ligelizumab (Qge031) Is A Next Generation Monoclonal Anti-Immunoglobulin E (Ige) Antibody. Ligelizumab Is Thought To Work By Blocking The Ige/Fceri Pathway, A Key Driver Of The Inflammatory Process In Csu. In A Phase Iib Dose-Finding Trial, More Patients Experienced Complete Resolution Of Wheals (Hives) With Ligelizumab Compared With Xolair (Omalizumab). No Safety Concerns Were Found With Ligelizumab Compared With Omalizumab Or Placebo In A Phase Iib Dose-Finding Trial In Csu Patients With Inadequate Control On Antihistamines.Ligelizumab Compared With Omalizumab Is Currently Being Investigated In Ongoing Phase Iii Clinical Trial Programs Including Pearl 1 And Pearl 2. The Clinical Trials Have Recruited More Than 2,000 Patients Globally Across 48 Countries And Results Are Expected In The Second Half Of 20219

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!