EC Approves Novartis' Xolair For CSU Indication

Novartis reported that the European Commission (EC) has approved Xolair (omalizumab) as add-on therapy for patients with chronic spontaneous urticaria (CSU) and who are unresponsive to antihistamines. The EC approval makes Xolair the first and only licensed therapy for the indication in the European Union.

David Epstein, Division Head of Novartis Pharmaceuticals, said “The EU approval of Xolair in CSU is truly exciting for patients with this chronic and debilitating skin disease. 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.”

Xolair is a targeted therapy that binds to and reduces immunoglobulin E (IgE), thereby impacting downstream effects on cellular activation mechanisms. The commission approved Xolair in adult and adolescent patients 12 years of age and older with inadequate response to H1-antihistamines, which can reach up to 50% of CSU patients.

Chronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria (CIU), is a severe and distressing skin condition characterized by red, swollen, itchy, and at times painful hives or wheals on the skin that spontaneously occur and recur for more than six weeks. Nearly half of patients with CSU also experience angioedema or swelling in the deep layers of the skin.

The drug’s EU approval follows the Committee for Medicinal Products for Human Use (CHMP) positive opinion, which was given based on positive results from three pivotal Phase III studies. The drug has also received approval for treatment of CSU in other countries including Turkey, Egypt, El Salvador, Bangladesh, and Guatemala. The company said it has currently ongoing regulatory reviews for Xolair in more than 20 countries including the US, Switzerland, Canada, and Australia.