NeLM news service
European CHMP issues positive opinion on extension of indication for omalizumab (Xolair ®)

Source: EMEA

Date published: 26/06/2009 14:45

Summary
by: Devika Sennik

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion, recommending the approval of an application to extend the licensed indications for omalizumab (Xolair ®). The extension will broaden the existing indication to paediatric patients from 6 to less than 12 years of age. Omalizumab is currently is used as add-on therapy to improve the control of severe persistent allergic asthma in adult and adolescent patients 12 years of age and over.

 

Further information is available in the positive opinion linked below.

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