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LONDON (Alliance News) - GlaxoSmithKline PLC said Thursday an advisory panel of US Food & Drug Administration has recommended against approval of mepolizumab for the treatment of chronic obstructive pulmonary disease, a type of lung condition that causes breathing difficulties.
Shares in the pharmaceutical company were trading 2.2% lower at 1,508.40 pence, one of the top fallers on the FTSE100 Index
Glaxo said the Pulmonary Allergy Drugs Advisory Committee has voted that the risk-benefit profile was not adequate to support approval of mepolizumab as an add-on treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease.
The panel also voted that there was not substantial evidence of the efficacy but there was adequate evidence of the safety of mepolizumab, the company said. The committee suggested further data to characterise the patient population that would be most likely to benefit from mepolizumab.
The US FDA advisory committees provide non-binding recommendations for consideration by the FDA.
"Having participated in today's advisory committee meeting and heard the recommendation we will continue to work with the FDA to address outstanding questions. We remain confident our data supports mepolizumab as a targeted treatment for patients continuing to experience COPD exacerbations guided by blood eosinophil count," Dave Allen, senior vice president of Glaxo's respiratory therapy research division said.
FDA Advisory Committees provide non-binding recommendations for consideration by the FDA. The Prescription Drug User Fee Act goal date for mepolizumab is 7 September 2018.
Mepolizumab is not currently approved for use in treatment of chronic obstructive pulmonary disease anywhere in the world and if approved it would be the first biologic therapy for patients with COPD.
The drug has been approved, under the brand name Nucala, in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with severe asthma. In the US, Canada and Japan it is approved as add-on maintenance treatment for patients with eosinophilic granulomatosis with polyangiitis.
