Regulatory Affairs

FDA advisory committee votes against approving GSK’s mepolizumab to treat COPD

PBR Staff Writer Published 27 July 2018

The Pulmonary Allergy Drugs Advisory Committee of the US Food and Drug Administration (FDA) has voted against recommending GlaxoSmithKline’s (GSK) mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts.

GSK said the committee voted on the basis of data presented that the risk-benefit profile was not adequate to support approval

In addition, the committee noted that there was not substantial evidence of the efficacy but there was adequate evidence of the safety of mepolizumab in this population.

GSK R&D respiratory therapy area senior vice president Dave Allen said: “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.”

Mepolizumab, which was first approved in 2015 for severe eosinophilic asthma, is the first-in-class monoclonal antibody that targets IL-5.

The drug is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, enabling to reduce blood eosinophils.

At present, mepolizumab has not yet secured approval for use in COPD in any part of the world, and if approved it would be the first biologic therapy for patients with COPD.

Mepolizumab has been developed to treat diseases, which are directed by inflammation linked to higher-than-normal eosinophils.

Mepolizumab was approved under the brand name Nucala in the US, Europe and more than 20 other markets, as an add-on maintenance treatment for patients with severe eosinophilic asthma.

The drug secured approval as add-on maintenance treatment for patients with eosinophilic granulomatosis with polyangiitis (EGPA) in the US, Canada and Japan

In November 2017, the company submitted biologics license application (sBLA) to the FDA for mepolizumab to be approved as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with COPD guided by blood eosinophil counts.

Mepolizumab was studies in over 3000 patients in 16 clinical trials across multiple eosinophilic indications. It is also presently being studied for severe hypereosinophilic syndrome and nasal polyposis.


Image: GlaxoSmithKline headquaters in Brentford, London. Photo: courtesy of Maxwell Hamilton.