New dermatology licence for Xolair

Xolair has gained EU approval as the first ever add-on therapy to treat chronic spontaneous urticaria (CSU) in adult and adolescent patients with inadequate response to H1-antihistamine treatment.

The approved dose is 300 mg by subcutaneous injection every four weeks.

"The EU approval of Xolair in CSU is truly exciting for patients with this chronic and debilitating skin disease," said David Epstein, division head of Novartis Pharmaceuticals. "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 quickly as possible in the EU."

Xolair (omalizumab) is being jointly developed by Novartis and Genentech, the biotech arm of Roche.

Prevalence of chronic urticaria (CU) is up to 1% of the world's population, and up to two thirds of these patients have CSU. CSU is also known as chronic idiopathic urticaria (CIU) in the US, and is a severe and distressing skin condition characterised by red, swollen, itchy and sometimes painful hives or wheals on the skin that spontaneously present and reoccur for more than six weeks. Up to 40% of CSU patients also experience angioedema, a swelling in the deep layers of the skin.

The EU approval was based on results from three pivotal Phase III studies involving nearly 1,000 patients with CSU not responding to H1-antihistamines. Xolair 300 mg met all primary and pre-specified secondary endpoints across these studies, which showed Xolair significantly improved itch and hives, including rapid itch relief, and in many cases completely cleared symptoms. Novartis says quality of life was also significantly improved for patients treated with Xolair 300 mg across the Phase III study programme. Negative effects of CSU on quality of life may include sleep deprivation and psychological comorbidities such as depression and anxiety.

Xolair has been approved for CSU in five countries outside the European Union: Egypt, Turkey, Guatemala, El Salvador and Bangladesh. Regulatory reviews are currently ongoing in more than 20 countries, including the US, Canada, Australia and Switzerland.