Copd

On July 4, 2011 the manufacturing company Novartis received an FDA approval for ArcaptNeohaler, a novel once daily bronchodialtor for chronic obstructive pulmonary disease. That a decision makes Arcapta the first once daily therapy in the long acting beta2agonist class to be approved in the U.S. for   maintenance treament of airflow obstruction in COPD patients. With       the millions of americans suffering from COPD I feel the approval for Arcapta is great news         for patients with this disease. COPD is a life threatening lung disease that makes it difficult to breathe. More than 12 million people are infected in the U.S., while another 12 million people       are believed to have the disease but remain undiagnosed. COPD also ranks as the third leading     cause of death I the U.S. and is a major cause serious long-term disabilities. Arcapta   75mcg         was studied in 641 patients in two key phase III trials lasting 12 weeks. The results at twelve       weeks showed that Arcapta improved lung function at 24 hours compared to placebo. Lung         function had also seen improvements five minutes after first dose and maintained over the             twelve week period, and it significantly reduced the need of rescue medications. In the U.S.         the clinical trial program evaluated safety in 2,516 patients who were given Arcapta for at least         twelve weeks at 75mcg doses or more, with the results supporting safety and tolerability profile.           There were adverse reactions in 449 patients given Arcapta 75mcg, which were cough, headache,         nasopharyngitis, nausea, and oropharngeal pain. In November 2009 Indacaterol was approved by       the European union under the brand name Onbrezbreehaler. It is currently approved in more than         60 countries for treatment of COPD, and is available in 30 countries with plans of launching more in 2011. The launch for Arcapta is planned for the first quarter of 2012. There are some warnings to be aware of... [continues]

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