FDA approves Xolair (omalizumab) for adults with nasal polyps - Seite 2

“With today’s approval, people living with nasal polyps now have a treatment option that targets IgE, an underlying driver of various allergic conditions,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are committed to understanding the full potential of Xolair across the spectrum of allergic diseases and are excited to provide this important treatment for people living with nasal polyps.”

Xolair is an injectable biologic medicine that is also FDA-approved for the treatment of moderate to severe persistent allergic asthma in people 6 years of age or older whose asthma symptoms are not controlled by inhaled corticosteroids, and for chronic idiopathic urticaria (CIU) in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines. Approximately 460,000 patients have been treated in the U.S. with Xolair since its initial approval for allergic asthma in 2003.² In the U.S., Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.

About Nasal Polyps
Nasal polyps is a commonly occurring and potentially debilitating condition in adults, impacting 13 million people in the U.S.^3,4 Currently, there are limited treatment options available and many patients opt for nasal surgery or systemic steroids. However, polyps may regrow over time. Nasal polyps present as noncancerous lesions on the lining of the nasal sinuses or nasal cavity associated with irritation and inflammation, which can block normal airflow.⁵ Nasal polyps may co-occur with other respiratory conditions, such as allergies and asthma.

About POLYP 1 and POLYP 2
In POLYP 1 and POLYP 2, the mean change from baseline at Week 24 for Xolair compared to placebo were: NPS, -1.1 versus 0.1 (95% CI: -1.6, -0.7) and -0.9 versus -0.3 (95% CI: -1.1, -0.1); NCS, -0.9 versus -0. 4 (95% CI: -0.8, -0.3) and -0.7 versus -0.2 (95% CI: -0.8, -0.2).1 POLYP 1 and POLYP 2 are the ninth and tenth Phase III trials for Xolair, respectively. Results from POLYP 1 and POLYP 2 were recently published in the Journal of Allergy and Clinical Immunology. No new or unexpected safety signals were identified in patients treated with Xolair, with over 95% of patients completing each safety arm of POLYP 1 and POLYP 2^.6 The most common adverse reactions (≥3% of patients) included headache, injection site reaction, arthralgia, upper abdominal pain and dizziness.