NOVARTIS PHARMA JAPAN FILES NDA FOR ASTHMA TREATMENT
June 26, 2006
Novartis Pharma Japan has filed a new drug application (NDA) for Xolair for subcutaneous injection, its proprietary agent for treating bronchial asthma (BA), with Japan's Ministry of Health, Labor and Welfare.
A recombinant humanized monoclonal anti-IgE antibody, Xolair (omalizumab) can exert beneficial effects with a once- or twice-per-month administration. In recent trials, the agent showed a significant improvement in patients with severe allergic bronchial asthma.
Xolair, which was approved in the U.S. in July 2003, is currently marketed in 15 countries, including the UK, Germany, Canada, Brazil and Australia.