Glaxo-Theravance Lung Drug Gains Backing of FDA Advisers
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GlaxoSmithKline Plc and Theravance Inc.’s Breo Ellipta should be approved to treat a lung disorder that is the third-leading cause of death in the U.S., advisers to the Food and Drug Administration said.
The companies provided substantial evidence the dry powder inhaler can treat airflow obstruction long-term and reduce exacerbations of chronic obstructive pulmonary disease, a panel of FDA advisers voted today in Silver Spring, Maryland. The agency is expected to decide whether to approve Breo by May 12.