US regulatory advisors are questioning the effectiveness of GlaxoSmithKline’s biologic Nucala as a treatment for patients experiencing a sudden worsening of chronic obstructive pulmonary disorder (COPD).
Nucala (mepolizumab) 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.
However, in documents posted on the FDA’s website ahead of an advisory committee meeting later this week, agency 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.
GSK filed the supplemental Biologics License Application in November last year on the back of data from two studies: METREX and METREO.
METREX showed a statistically significant reduction in the frequency of moderate and severe exacerbations for mepolizumab 100mg 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 mepolizumab compared to placebo, the difference did not reach statistical significance.
COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both and limits airflow to the lungs, interfering with normal breathing. It is thought to affect 384 million people across the globe, and currently the fourth leading cause of death.