GlaxoSmithKline’s bid to expand the use of its biologic Nucala in the US to include patients with coronary pulmonary obstructive disorder (COPD) has hit a significant setback.
The company is seeking approval for Nucala (mepolizumab) 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.
However, the US Food and Drug Administration has now issued a complete response letter asking for more clinical data to support approval of the drug in this setting.
Nucala is a monoclonal antibody – already approved for asthma – that works by inhibiting interleukin-5 (IL5) to decrease the maturation and survival of eosinophils, overproduction of which can cause inflammation in the lungs.
GSK filed for the drug’s approval for COPD on the basis of two trials – METREX and METREO.
METREX showed a statistically significant reduction in the frequency of moderate and severe exacerbations for Nucala compared to placebo in patients with a broad range of eosinophil counts.
However, while METREO, which included just patients with higher eosinophil levels, showed a reduction in the frequency of moderate and severe exacerbations for Nucala compared to placebo, the difference did not reach statistical significance.
Back in July, FDA staff highlighted difficulties in determining whether inhibiting IL5 is a relevant therapeutic approach for COPD, and queried whether GSK had enough efficacy data to back use of Nucala in this setting.
In a short statement, GSK said it would “work closely with the FDA to determine the appropriate next steps” for the application.
