Press Release : FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

   --  Xolair for self-injection offers healthcare providers and 
appropriate patients another administration option for more flexibility 
in managing their treatment 
 
 
 
 
 
   Basel, 13 April 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today 
announced that the U.S. Food and Drug Administration (FDA) has approved 
the company's supplemental Biologics License Application for Xolair(R) 
(omalizumab) prefilled syringe for self-injection across all approved 
U.S. indications.(1) Xolair is the only FDA-approved biologic designed 
to target and block immunoglobulin E (IgE) for the treatment of moderate 
to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) 
and nasal polyps. 
 
 
 
   "Today's approval reflects our commitment to continued innovation with 
Xolair to address the critical needs of people living with allergic and 
inflammatory conditions," said Levi Garraway, M.D., Ph.D., Roche's Chief 
Medical Officer and Head of Global Product Development. "Appropriate 
patients will now have the flexibility to administer Xolair from home, 
which is particularly important for those who are considered high-risk 
during the COVID-19 pandemic." 
 
 
 
   Before starting self-injection with Xolair prefilled syringe, the 
patient must have no prior history of anaphylaxis and be closely 
observed by a healthcare provider for at least three injections with no 
hypersensitivity (allergic reactions). After Xolair therapy has been 
initiated and safely established in a healthcare setting, a healthcare 
provider may determine whether self-injection with Xolair prefilled 
syringe by the patient or a caregiver is appropriate. The healthcare 
provider must train the patient or caregiver on the correct subcutaneous 
injection technique, how to recognize the signs and symptoms of 
anaphylaxis and how to treat anaphylaxis appropriately, before the first 
self-injection outside a healthcare setting. 
 
 
 
   "Expanding treatment options for personalised care and self-management 
is always welcome news for the patient community," said Kenneth Mendez, 
CEO and President, Asthma and Allergy Foundation of America. "The 
possibility of administering FDA-approved treatment outside of the 
healthcare provider's office, but still guided by that healthcare 
provider, may reduce barriers to care for patients and their 
caregivers." 
 
 
 
   Approximately 460,000 patients have been treated in the U.S. with Xolair 
since its initial approval in 2003.(2) The use of Xolair across allergic 
asthma, CIU and nasal polyps is based on its well-established efficacy 
and safety profile and supported by a robust clinical development 
program, including 10 Phase III studies.(1) 
 
 
 
   In the U.S., Genentech, a member of the Roche group, and Novartis 
Pharmaceuticals Corporation work together to develop and co-promote 
Xolair. 
 
 
 
   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(R) /RoActemra(R) 
(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(R) /MabThera(R) (rituximab) for 
rheumatoid arthritis granulomatosis with polyangiitis and microscopic 
polyangiitis and for pemphigus vulgaris (PV); Xolair(R) (omalizumab) for 
allergic asthma and chronic idiopathic urticaria (CIU); Pulmozyme(R) 
(dornase alfa) for cystic fibrosis; and Esbriet(R) (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. 
 
 
 
   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 
twelfth 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 2020 employed more than 100,000 people worldwide. 
In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 
58.3 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 
https://www.globenewswire.com/Tracker?data=aABM8KVv25tJAR3pdPYRHXvFNO4sX8unaiC2Q3tJmXXhPP-pMIdtggCzAG9qaPmXmTq1VPdiysJG9kVg_KXCWw== 
www.roche.com. 
 
 
 
   All trademarks used or mentioned in this release are protected by law. 
 
 
 
   References 
 
   [1] Xolair(R)  Full Prescribing Information. Genentech, Inc.; November 
2020. 
 
   [2] Data on file. Genentech, Inc. 
 
 
 
   Roche Group Media Relations 
 
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(END) Dow Jones Newswires

April 13, 2021 01:00 ET (05:00 GMT)