The Ministry of Food and Drug Safety (MFDS) has approved biologic Xolair to treat patients 12 years or older with chronic spontaneous urticaria (CSU) who have been unresponsive to antihistamines.

Xolair (ingredient: omalizumab) is the first and only biologic treatment approved to treat CSU, Novartis Korea said. It also gained the ministry’s approval to treat allergic asthma in 2007.

CSU is a skin disease that causes itchy hives and swelling (angioedema) on all parts of the body without reason or warning. The hives can appear anywhere on the body including inside the throat that can cause difficulty breathing. The disease is diagnosed when a person experiences symptoms for at least six weeks. It persists for an average of one to five years.

Although oral histamines are used as initial treatment, studies found more than 50 percent of patients did not respond to the treatment while around 30 percent did not experience alleviation of symptoms despite increasing the dosage four-fold, the company said.

The ministry approved Xolair based on the safety and efficacy of the drug proven in three global phase 3 trials – ASTERIA I, ASTERIA II, GLACIAL – and one domestic phase 3 trial POLARIS.

“We found around 90 percent of CSU patients responded to the injection within a month in the clinical setting, and 40 percent responded within a day,” said Torsten Zuberbier, director of the Allergie-Centrum-Charité in Berlin. “I am pleased that CSU patients in Korea will have the opportunity to get appropriate treatment with Xolair’s approval in Korea and hope that it dramatically improves the patient’s quality of life lowered by the disease.”