Novartis submits Xolair for Japanese clearance

Swiss drug major Novartis has submitted an application to the Japanese health authorities for the approval of Xolair (omalizumab), its novel asthma therapy targeting the root cause of allergic disease.

The Basle-headquartered group believes the agent offers an entirely new approach to the treatment of severe asthma and noted that worldwide clinical trials have shown the potential, adding that it is already approved in the USA and European Union for controlling symptoms and reducing asthma exacerbations and the need for emergency medical treatment, even in patients with the most severe forms of the disease that are poorly-controlled by existing drugs.

Novartis noted that an estimated four million people suffer with asthma in Japan and, despite advances in therapy, approximately 20% of those with severe disease have symptoms that remain inadequately controlled. Although the number of fatalities is falling, approximately 3,000 people still die of the condition in Japan each year.