FDA Says ‘Not So Fast’ on Proposed COPD Drug

The Food and Drug Administration wants more information on an experimental drug proposed for treatment of chronic obstructive pulmonary disease, a life-threatening lung condition also called “smoker’s lung” that affects an estimated 24 million Americans.

Novartis AG has asked the FDA to approve the drug, called QAB149, to treat COPD, the fourth leading cause of death in the United States. More than 120,000 deaths each year are caused by COPD.

COPD is actually the name for a group of separate conditions including chronic bronchitis and emphysema that cause obstructed airflow out of the lungs. Symptoms of COPD include shortness of breath (also called dyspnea), chronic cough, mucus production with cough and wheezing. Unlike many diseases, COPD is entirely preventable and easily treatable if detected early. About 85% of COPD cases are diagnosed in smokers.

The FDA indicated it is still reviewing data submitted by Novartis about the proposed drug and that additional clinical studies may be required in the future to garner approvals, according to an Associated Press report. The European Medicines Agency recently recommended approval of the drug, which some analysts said may support an FDA approval.

Novartis reportedly plans to market its new COPD drug along with other drugs and products being developed by other drug companies, but the combination therapies may not be ready until 2013, the AP reports.

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