FDA advisory committee negative recommendation for mepolizumab as an add-on treatment for the reduction of exacerbations in patients with COPD.- GSK.

GlaxoSmithKline plc announced the outcome of the Pulmonary Allergy Drugs Advisory Committee of the FDA meeting on the use of mepolizumab (Nucala) as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts.

The committee voted on the basis of data presented that the risk-benefit profile was not adequate to support approval (3 for, 16 against).The committee also voted that there was not substantial evidence of the efficacy (3 for, 16 against) but there was adequate evidence of the safety (17 for, 2 against) of mepolizumab in this population and the committee suggested further data to characterise the patient population that would be most likely to benefit from this targeted biologic therapy.

The FDA Advisory Committee provided a non-binding recommendation for consideration by the FDA. The Prescription Drug User Fee Act (PDUFA) goal date for mepolizumab is 7 September 2018.