Novartis: OmalizumabAchieved all Targets in Phase III Safety Registration
An announcement made by the Swiss drugmaker Novartis AG (NVS: Quote) on Wednesday suggested about the late-breaking results omalizumab clearing all the primary and secondary endpoints of a pivotal Phase III safety registration study in chronic spontaneous urticaria or CSU.
It is a chronic and debilitating form of hives with partial approved treatment options. GLACIAL is considered as the second of three pivotal Phase III studies. These studies conduct analysis about the efficacy and safety of omalizumab in CSU.
The result derived from the study supported supported the efficacy, safety and tolerability of omalizumab in patients with refractory CSU. It is a kind of chronic and debilitating skin disease with obstinate itch and hives.
Near about 40 percent of CSU patients were unsuccessful on ntihistamines. These include those who were taking the approved dose even for the fourth time. The doses, in terms of official regulations are currently available only for treatment for CSU.
However, Omalizumab is presently not at all approved or indicated for CSU. Supervision of the submissions for omalizumab in CSU is scheduled for later times in the current year. It is a collaborated effort of Novartis and Genentech, Inc.
The data was brought forward for the first time at the European Academy of Allergy and Clinical Immunology-World Allergy Organization World Allergy and Asthma Congress 2013 in Milan which is located in Italy.