Novartis reports Omalizumab Met All Primary and Secondary Endpoints in Pivotal GLACIAL Study

Novartis NVS reports new Phase III data showing omalizumab significantly improves itch in patients with severe form of chronic skin disease CSU[1] . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. Omalizumab met all primary and secondary endpoints in pivotal GLACIAL study of patients with refractory chronic spontaneous urticaria (CSU)[1] Omalizumab found to be effective, safe and well tolerated in refractory CSU patients, including those on antihistamines at up to four times the approved dose[1] By Week 12 omalizumab eliminated or suppressed symptoms in more than half of patients who failed multiple therapies; benefit sustained during active treatment[1]  Basel, June 26, 2013 - Novartis announced today late-breaking results showing omalizumab met all primary and secondary endpoints of a pivotal Phase III safety registration study in chronic spontaneous urticaria (CSU)[1], a chronic and debilitating form of hives with limited approved treatment options[2-4]. The data was presented for the first time at the European Academy of Allergy and Clinical Immunology-World Allergy Organization (EAACI-WAO) World Allergy and Asthma Congress 2013 in Milan, Italy. Omalizumab is not currently approved or indicated for CSU. Regulatory submissions for See full press release