Novartis has received approval from the European Commission (EC) to use Xolair (omalizumab) as an add-on therapy to treat chronic spontaneous urticaria (CSU) in adult and adolescent patients 12 years and above with inadequate response to H1-antihistamines.
The company said that approved dose of Xolair is 300mg administered by subcutaneous injection every four weeks.
In the US, CSU is also called as chronic idiopathic urticaria (CIU) 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.
Novartis Pharmaceuticals division head David Epstein said: "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 Xolairas quickly as possible in the EU."
The EU approval follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on Xolair.
Approval was based on positive and consistent results from three pivotal Phase III registration studies (ASTERIA I, ASTERIA II and GLACIAL) that involved about 1,000 patients with CSU not responding to H1-antihistamines.
In Phase III studies, Xolair 300mg met all primary and pre-specified secondary endpoints.
The studies showed that Xolair had improved itch and hives, including rapid itch relief, and in many cases completely cleared symptoms.
According to these studies, negative effects of CSU on quality of life may include sleep deprivation and psychological comorbidities such as depression and anxiety.
In the ASTERIA II study, 44% of patients receiving Xolair 300mg were itch-and hive-free after 12 weeks of treatment and in the ASTERIA I study, patients have experienced a rapid reduction in itch and hives as early as Week 1, with the therapeutic benefit sustained over 24 weeks of active treatment.
The GLACIAL study showed that over half of patients had failed multiple therapies including H1-antihistamines (at up to four times the approved dose) and H2-antihistamines and/or leukotriene receptor antagonists (LTRAs).
Apart from the EU, Xolair has been approved for the treatment of CSU in five countries: Egypt, Turkey, Guatemala, El Salvador and Bangladesh.
Regulatory reviews of Xolair, which is being jointly developed by Novartis and Genentech, are currently ongoing in over 20 countries, including the US, Canada, Australia and Switzerland.