GlaxoSmithKline’s (GSK) interleukin-5 (IL-5) inhibitor has received approval from the US Food and Drug Administration (FDA) for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP).
Following the approval, Nucala (mepolizumab) becomes the first anti-IL-5 biologics for adult patients with CRSwNP in the US.
The FDA has cleared Nucala as an add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.
The approval is based on data from GSK’s SYNAPSE study which evaluated the effect of Nucala versus placebo in over 400 patients with CRSwNP.
In this trial, Nucala achieved significant improvement in reducing the size of nasal polyps and nasal obstructions. In addition, in the SYNAPSE study there was a 57% reduction in the proportion of patients who had surgery in the group treated with Nucala versus placebo.
The number of patients requiring systemic corticosteroid use during the 52-week treatment period was also lower in the group receiving Nucala treatment.
“More than 5 million people in the US suffer with chronic rhinosinusitis with nasal polyps and today’s approval provides these patients with the first anti-IL-5 treatment option and an alternative to surgery to help reduce symptoms of this disease,” said Hal Barron, chief scientific officer and president of R&D at GSK.
“GSK is committed to exploring the role of IL-5 inhibition in eosinophil-driven diseases to help address unmet needs of patients,” he added.