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Novartis AG Announces Positive Results From Final Phase III Omalizumab Registration Study In Severe Form Of Chronic Skin Disease CSU


Saturday, 5 Oct 2013 04:36am EDT 

Novartis AG announced new results from the Phase III ASTERIA I study showing omalizumab was effective and safe in the treatment of chronic spontaneous urticaria (CSU)1, a chronic and debilitating form of hives. ASTERIA I is the final pivotal registration study for omalizumab in CSU to be announced, and results were presented for the first time at the 22nd Congress of the European Association of Dermatology and Venereology (EADV) in Istanbul, Turkey. Omalizumab is currently not approved for the treatment of CSU. The ASTERIA I data support the positive and consistent results from two previously reported pivotal Phase III registration studies of omalizumab in CSU (ASTERIA II and GLACIAL), which were presented at major medical congresses earlier this year. Regulatory applications for omalizumab in CSU were filed with US and EU health authorities in the third quarter of 2013, based on data from nearly 1,000 patients included in these Phase III studies. The positive new data clearly show the potential of omalizumab to treat CSU, a disease where more than 50% of patients don't respond to approved doses of antihistamines, the only licensed treatment option. Specifically, the ASTERIA I study showed that patients treated with omalizumab responded as early as Week 1 (300 mg dose), compared to Week 4 in the placebo group (p= <0.0001).