Novartis Korea said Monday that the National Center for Biotechnology Information published a new guideline that recommended its chronic spontaneous urticaria (CSU) treatment Xolair for patients who do not respond to antihistamines.
The guideline, drafted by four major allergy associations -- the European Academy of Allergy and Clinical Immunology (EAACI), the Global Allergy and Asthma European Network (GA2LEN), the European Dermatology Forum (EDF), and the World Allergy Organization (WAO) -- was published earlier this month.
Xolair is the only approved biologic drug, indicated to treat CSU as an add-on therapy. It first gained the Ministry of Food and Drug Safety’s approval as a CSU therapy last September. Xolair is also approved to treat moderate-to-severe or severe persistent allergic asthma.
Chronic urticaria, including CSU, is a skin disease that causes itchy hives and swelling (angioedema) on all parts of the body without reason or warning. The new guideline recommends Xolair as the only treatment qualified with excellent efficacy and proper safety for CSU, the company said.
The ministry approved Xolair based on the safety and efficacy of the drug proven in three global phase 3 trials – ASTERIA I, ASTERIA II, GLACIAL – and one domestic phase 3 trial POLARIS.