Swiss drugmaker Novartis International AG (NVS) announced positive opinion from the Committee for Medicinal Products for Human Use or CHMP for the use of Xolair as an add-on therapy for chronic spontaneous urticaria or CSU in adult and adolescent patients 12 years and above with inadequate response to H1 antihistamines. The recommended dose is 300 mg by subcutaneousinjection every four weeks. Xolair showed consistent high efficacy across three Phase III CSU trials and in many cases completely cleared symptoms with safety comparable to placebo.
Tim Wright, Global Head of Development, Novartis Pharmaceuticals, noted: "If approved, Xolair will be the first and only licensed therapy in the EU for up to 50% of CSU patients not responding to approved doses of antihistamines."
The CHMP opinion was based on positive and consistent results from three pivotal Phase III registration studies namely ASTERIA I, ASTERIA II and GLACIAL, which involved around 1,000 patients with CSU not responding to antihistamines. Xolair 300 mg achieved all primary and pre-specified secondary endpoints across these studies, showing that Xolair significantly improved itch and hives, including rapid itch relief, and in many cases completely cleared symptoms.
Xolair, that is being jointly developed by Novartis and Genentech, Inc. for CSU, has already been approved to treat CSU in 4 countries such as Egypt, Turkey, Guatemala and El Salvador. Currently, regulatory reviews are ongoing in over 20 countries, including the US, Canada, Australia and Switzerland.
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December 19, 2025 15:10 ET U.S. inflation data and interest rate decisions by major central banks were the highlights of this busy week for economics news flow. Employment data and survey results on the housing markets also gained attention in the U.S. In Europe, the European Central Bank and Bank of England announced their policy decisions and macroeconomic projections.