Novartis announced that the US FDA has approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), an unpredictable and debilitating skin disease that is known as chronic spontaneous urticaria (CSU) outside of the US. In the US, Xolair is indicated for CIU in adults and adolescents who remain symptomatic despite H1-antihistamine treatment. Until now, H1-antihistamines have been the only approved therapy for CIU in the US.
CIU / CSU is a severe and distressing skin condition characterised by red, swollen, itchy and sometimes painful hives on the skin that spontaneously present and re-occur for more than six weeks. Up to 40 per cent of CIU / CSU patients also experience angioedema, a swelling in the deep layers of the skin.
“This approval from the FDA is great news for patients in the US suffering from CIU, a skin disease known as CSU in other parts of the world,” said David Epstein, Division Head of Novartis Pharmaceuticals. “Up to 50 per cent of patients do not respond to approved doses of H1-antihistamines, which up until now have been the only licensed treatment for CIU in the US.”
At any given time, the prevalence of chronic urticaria (CU) is up to one per cent of the world’s population, and up to two thirds of these patients have CIU / CSU. In the US, it is estimated that approximately 1.5 million people suffer from CIU. Women are twice as likely than men to have the condition and most people develop symptoms between the ages of 20 and 40.
The US FDA approval is primarily based on positive and consistent results from two landmark phase III studies, ASTERIA I and II, which involved CIU / CSU patients not responding to approved doses of H1-antihistamines.
EP News Bureau – Mumbai