Novartis seeks Japanese approval of Xolair for asthma

By Lisa Kerner

Charlotte, N.C., June 26 - Novartis said it submitted an application to the Japanese Ministry of Health, Labor and Welfare seeking approval for Xolair (omalizumab), its novel therapy for the treatment of severe asthma.

If approved, Xolair would become the first monoclonal antibody to be approved for the treatment of asthma in Japan, according to a company news release.

The application was supported by data from a clinical study showing a significant improvement in patients' lung function, as measured by peak expiratory flow (PEF) when treated with Xolair.

In the multicenter, randomized, double-blind, parallel-group, placebo-controlled study, 315 patients with moderate to severe allergic asthma received 16 weeks' treatment with Xolair or placebo.

The PEF in patients receiving Xolair increased by a mean of 15.45 L/min over baseline, compared to 2.25 L/min in patients receiving a placebo.

Approved for use in the United States and the European Union, Xolair is given by injection every two or four weeks to block the action of the Immunoglobin E antibody, which causes of inflammation of the airways.

Xolair has been developed under an agreement between Novartis Pharma AG, Genentech Inc. and Tanox Inc.

Novartis, based in Basel, Switzerland, researches, develops, manufactures and markets health care products.

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