Novartis: Xolair gets European OK as add-on therapy for chronic spontaneous urticaria

Novartis has announced that omalizumab has been approved by the European Commission as an add-on therapy for chronic spontaneous urticaria in adults and adolescents with inadequate response to H1-antihistamine treatment.

Omalizumab (Xolair), jointly developed by Novartis and Genentech, is a targeted therapy that binds to immunoglobulin E (IgE) and suppresses histamine-induced skin reactions, according to a press release. The approved dose is a 300-mg subcutaneous injection every 4 weeks as an add-on therapy for patients aged 12 years and older. Regulatory review for treatment of chronic spontaneous urticaria (CSU) is ongoing in the US, where omalizumab is approved for moderate to severe persistent allergic asthma.

The EC approval was based on a European Medicines Agency committee’s opinion of three phase 3 studies involving 976 patients (aged 12 to 75 years) with moderate to severe CSU who were unresponsive to H1-antihistamines. Primary and secondary study endpoints were met by 300-mg omalizumab treatment, “which showed that Xolair significantly improved itch and hives, including rapid itch relief and in many cases completely cleared symptoms,” the release said.

Patients also reported significant improvement in quality of life, although sleep deprivation and psychological comorbidities, including depression and anxiety, also occurred.

“With this new therapeutic option from our specialty dermatology portfolio, our aim is to help ensure that the up to 50% of patients who suffer from CSU and don’t respond to approved doses of antihistamines have access to Xolair as quickly as possible in the EU,” David Epstein, division head of Novartis Pharmaceuticals, said in the release.