FDA approves Xolair (omalizumab) for adults with nasal polyps - Seite 3

POLYP 1 and POLYP 2 are replicate Phase III pivotal studies designed to determine the efficacy and safety of Xolair compared with placebo in adult patients with nasal polyps who had an inadequate response to nasal corticosteroids. Both trials were randomized, multicenter, double-blind and placebo-controlled. POLYP 1 involved 138 patients, and POLYP 2 involved 127 patients. The co-primary outcomes for both trials were change from baseline to Week 24 in average daily Nasal Congestion Score and Nasal Polyp Score. Patients in the studies were administered either Xolair or placebo by subcutaneous injection every two to four weeks in addition to background nasal mometasone therapy during both the treatment period and a five-week run-in period.¹

About Xolair
Xolair is the only approved antibody designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade.

About Roche in Immunology
The Roche Group’s immunology medicines include: Actemra/RoActemra (tocilizumab) for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and giant cell arteritis (GCA) and for the treatment of severe or life-threatening chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome (CRS); Rituxan/MabThera (rituximab) for rheumatoid arthritis granulomatosis with polyangiitis and microscopic polyangiitis and for pemphigus vulgaris (PV); Xolair (omalizumab) for allergic asthma and chronic idiopathic urticaria (CIU); Pulmozyme (dornase alfa) for cystic fibrosis; and Esbriet (pirfenidone) for idiopathic pulmonary fibrosis (IPF). Roche has more than 15 investigational medicines in clinical development for immunological diseases that include asthma, autoimmune diseases, rheumatoid arthritis, ulcerative colitis and Crohn's disease.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.