U.S. FDAs Stamp of Approval for Xolair Drug Developed by Novartis and Genentech


Published Date : Mar 28, 2014

The United States Food and Drug Administration (FDA) has stamped its mark of approval for Xolair (omalizumab), a drug developed by Novartis and Genentech. Xolair has been developed for treating a debilitating skin condition that is known as chronic idiopathic urticaria (CIU). The occurrence of this condition is unpredictable, and outside of the United States this disease is also known by another name--chronic spontaneous urticaria (CSU).

The company was reported as stating that the drug’s new use is suitable for those aged 12 years or older, and those who continue to show symptoms of the disease despite being subjected to the H1-antihistamine therapy.

Thus far, H1-antithistamines were the only available therapy for CIU that was approved by authorities. However, nearly 50% of patients being treated with this therapy showed an inadequate response.

Sandra Horning, CMO and head of global product development at Genentech said that CIU is a disease that’s particulary difficult to manage given its unknown causes. Till date, the usage of other approved medicines hadn’t proven effective enough for a number of patients suffering from this disease. Speaking after the approval of the drug, Horning said that the company was pleased that patients suffering from this debilitating skin condition now had access to a new treatment option.

According to the company, CIU is a severe skin condition that causes considerable distress to those suffering from it. Its symptoms include itchy, swollen and red hives that appear on the skin that can also sometimes be painful. These hives can re-occur for periods of over six weeks. 

The new drug Xolair is administered via injection, and needs a prescription. The drug that has been developed jointly by Genentech along with Novartis Pharma is co-promoted in the America market with the Novartis Pharmaceuticals Corporation.