EU Regulators Recommend Xolair for Hives


January 24, 2014

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 also has recommended revising the label indication for ustekinumab (Stelara, Janssen-Cilag International) for moderate to severe plaque psoriasis. Candidates for ustekinumab now will include patients who have not responded adequately to psoralen and ultraviolet A (PUVA) and those who cannot tolerate PUVA or have a contraindication to it.

CHMP's recommendations on omalizumab and ustekinumab await a final decision from the European Commission, the executive branch of the EU.


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