XOLAIR (omalizumab), anti-IgE
DERMATOLOGY - New indication
Opinions on drugs - Posted on Jun 24 2015
Reason for request
Extension of indication
Minor improvement in the treatment of spontaneous chronic urticaria unresponsive to anti-H1 antihistamines
- XOLAIR now has Marketing Authorisation, as an additional treatment, in the treatment of spontaneous chronic urticaria (SCU) in patients from the age of 12 years with an inadequate response to anti-H1 antihistamine treatments.
- Its efficacy has been demonstrated versus placebo as an additional treatment, particularly in terms of the percentage of patients with good control of the disease. The effects observed are purely transient and resolve as soon as treatment is stopped, in the 6th month.
- Omalizumab was well tolerated in the studies, however cardiovascular risks and those related to the immunosuppressive effect (particularly carcinogenic) have not been evaluated in the long term.
Clinical Added Value
Évaluation des médicaments
HAS opinions and decisions