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
