FDA advisory panel votes against backing GlaxoSmithKline's Nucala for COPD

GlaxoSmithKline announced Wednesday that it has not obtained FDA advisory panel support for Nucala (mepolizumab) as an add-on to inhaled corticosteroids for the treatment of exacerbations of chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts. Dave Allen, head of the company's respiratory therapy area, said GlaxoSmithKline "will continue to work with the FDA to address outstanding questions," but added "we remain confident our data supports [Nucala] as a targeted treatment for patients continuing to experience COPD exacerbations guided by blood eosinophil count." 

In the meeting, committee members voted 16-3 that the data did not provide substantial evidence of efficacy and urged GlaxoSmithKline to further characterise the patient population most likely to benefit from the therapy. However, the panel voted 17-2 that there was adequate evidence backing the safety of Nucala for this indication.

In documents released ahead of the advisory panel meeting, FDA staff also questioned the effectiveness of Nucala for reducing COPD exacerbations. Last year, GlaxoSmithKline reported Phase III results showing that while the IL-5 antagonist had significantly reduced the frequency of moderate and severe COPD exacerbations versus placebo in one trial, significance was not achieved in a second study.

FirstWord reports in this therapy area - KOL Insight Chronic Obstructive Pulmonary Disorder (COPD): Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more. 

GlaxoSmithKline submitted an FDA filing last November seeking clearance of Nucala for use in COPD patients with an eosinophilic phenotype. The UK drugmaker also recently outlined plans to offset anticipated lower Advair (fluticasone propionate/salmeterol) sales with revenue from newer respiratory products. 

Nucala was cleared in the US in 2015 as an add-on maintenance treatment for patients aged 12 years and older with severe asthma and an eosinophilic phenotype. According to GlaxoSmithKline, the FDA is scheduled to decide whether to approve Nucala for the new indication by September 7, and if approved, "it would be the first biologic therapy for patients with COPD" anywhere in the world.

For related analysis, see ViewPoints: GlaxoSmithKline faces uphill battle in bid to secure COPD approval for Nucala. See also ViewPoints: A limited opportunity for new biologics in COPD is getting smaller.


To read more Top Story articles, click here.