Novartis receives CHMP recommendation for new Xolair approval

Novartis has announced that its drug Xolair has received a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for approval in a new indication.

The committee has recommended the omalizumab therapy be approved in Europe as an add-on treatment for chronic spontaneous urticaria (CSU) in adult and adolescent patients with inadequate response to H1 antihistamine treatment.

Data from three pivotal phase III registration studies involving nearly 1,000 patients revealed that Xolair significantly improved levels of itching and hives associated with the disease and in many cases completely cleared symptoms, while also enhancing quality of life.

The European Commission generally follows the recommendations of the CHMP and is expected to issue its final decision within two months.

Tim Wright, global head of development at Novartis Pharmaceuticals, said: "If approved, Xolair will be the first and only licensed therapy in the EU for up to 50 percent of CSU patients not responding to approved doses of antihistamines."

Xolair is already approved for the treatment of asthma and received a recommendation from the UK's National Institute for Health and Care Excellence in this indication last year.