Glaxo-Theravance Lung Drug Shows Strong Efficacy, FDA Say
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GlaxoSmithKline Plc and Theravance Inc.’s combination treatment for a lung disease that is the No. 3 cause of death in the U.S. showed strong efficacy at both doses the companies sought for approval, regulators said.
Studies found the once-daily inhaled therapy, called Anoro Ellipta, works against chronic obstructive pulmonary disorder, though missing data may limit the reliability of the findings, Food and Drug Administration staff said today in a report. An advisory panel is scheduled to discuss the drug Sept. 10, and the FDA is expected to decide by Dec. 18 on approval.