FDA accepts supplemental biologics license application for Xolair (omalizumab) for the treatment of nasal polyps
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
- The submission is based on positive results from the Phase III POLYP 1 and POLYP 2 studies of Xolair in adults with chronic rhinosinusitis with nasal polyps with inadequate response to intranasal corticosteroids
- If approved, Xolair would become the first antibody to help reduce the size of nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E
- Frequently co-occurring with other respiratory conditions, nasal polyps is a chronic condition and causes a range of symptoms impacting patients? lives including loss of sense of smell and nasal congestion
About POLYP 1 and POLYP 2
POLYP 1 and POLYP 2 are replicate Phase III studies designed to determine the efficacy and safety of Xolair compared with placebo in adult patients with CRSwNP who have had an inadequate response to intranasal corticosteroids. Both trials were randomized, multicenter, double-blind and placebo-controlled. POLYP 1 included 138 patients and POLYP 2 included 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 intranasal corticosteroid.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 several investigational medicines in clinical development for immunological diseases including autoimmune disorders, 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. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit?www.roche.com.All trademarks used or mentioned in this release are protected by law.