Swiss drugmaker Novartis AG said Friday that Japanese regulators approved its lung disease drug Onbrez.
Novartis said the Japanese Ministry of Health, Labor and Welfare approved Onbrez as a treatment for symptoms of chronic obstructive pulmonary disease, a condition that includes conditions like chronic bronchitis and emphysema. Onbrez is inhaled once per day using the company's Breezhaler device. It is designed to start working in five minutes.
Novartis said chronic obstructive pulmonary disease could affect as many as 5.3 million people in Japan.
The U.S. Food and Drug Administration is scheduled to make a decision on Onbrez in July. An advisory panel has recommended the agency approve marketing of the drug. If it is approved, Novartis will market it under the name Arcapta Neohaler. European Union regulators approved Onbrez in November 2009.
Novartis shares fell 25 cents to $60.86 in afternoon trading.