U.K.-based GlaxoSmithKline PLC said the U.S. Food and Drug Administration rejected Nucala as an add-on treatment for patients with a certain type of lung disease.
The drugmaker is seeking approval for Nucala, or mepolizumab, as an add-on to corticosteroid-based maintenance therapy to lessen the severity of symptoms of chronic obstructive pulmonary disease. The agency asked for more clinical data.
GSK plans to work with the U.S. regulator to determine next steps for the application.
The rejection came weeks after the U.S. FDA's Pulmonary Allergy Drugs Advisory Committee questioned the effectiveness of Nucala and voted against its approval, questioning the drug's risk-benefit profile.
Nucala is already approved for patients with severe asthma in the U.S.