Novartis receives European CSU approval for Xolair

Novartis has announced that its drug Xolair has been approved by the European Commission for use in the treatment of chronic spontaneous urticaria (CSU).

The product has been ratified for use as an add-on therapy for the treatment of CSU in adult and adolescent patients with inadequate response to H1-antihistamine treatment. It becomes the first and only licensed therapy for this indication in the EU.

It is a valuable new treatment option for the unpredictable skin disease, which is characterised by a debilitating form of chronic itch, hives and angioedema that can have a severe negative impact on quality of life.

Data from three pivotal phase III registration studies involving nearly 1,000 patients revealed that Xolair can significantly improve levels of itching and hives associated with the disease and in many cases completely cleared symptoms, while also enhancing quality of life.

David Epstein, division head of Novartis Pharmaceuticals, said: "Our aim is to help ensure that the up to 50 percent of patients who suffer from CSU and don't respond to approved doses of antihistamines have access to Xolair as quickly as possible."