Drug regulators in the European Union (EU) have recommended approving omalizumab ( Xolair, Novartis, Genentech) as an add-on therapy for patients with chronic spontaneous urticaria (CSU), the European Medicines Agency (EMA) announced today.
Omalizumab already is approved in the EU as an add-on therapy for allergic asthma. Yesterday the EMA's Committee for Medicinal Products for Human Use (CHMP) cleared the drug for patients 12 years of age and older with CSU who have not responded adequately to H1 antihistamine treatment.
The US Food and Drug Administration (FDA) okayed omalizumab as a stand-alone therapy for allergic asthma in 2003. Four years later, the agency added a boxed warning to the drug's label about the risk for life-threatening anaphylaxis. The FDA is weighing whether to follow CHMP's lead and approve the drug for CSU.
CHMP's recommendations on omalizumab and ustekinumab await a final decision from the European Commission, the executive branch of the EU.
From Medscape Medical News
Dr Kenneth Backman from Allergy & Asthma Care of Fairfield County comments: "Studies have demonstrated that Xolair can lead to dramatic improvement in patients with difficult-to-treat hives. The FDA is expected to approve Xolair for this condition soon, and we look forward to being able to offer this to patients. There are some insurance companies that already cover this for severe hives, so patients suffering from chronic hives should contact us for additional information."