FDA Approves GSK’s Treatment for Chronic Rhinosinusitis with Nasal Polyps

GSK announced that FDA has approved a new indication for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5.

GlaxoSmithKline (GSK) announced on July 29, 2021 that FDA has approved Nucala (mepolizumab) as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). This is a new indication for mepolizumab, which is a monoclonal antibody that targets interleukin-5 (IL-5).

Mepolizumab is the first IL-5 therapy approved as an add-on treatment in the United States for adults with CRSwNP to target eosinophilic inflammation. This new indication is for the add-on maintenance treatment of CRSwNP in adult patients 18+ with inadequate response to nasal corticosteroids.

In the US, mepolizumab is approved for four indications in eosinophil-driven diseases to date:

  • Biologic therapy indicated for patients 6+ with severe eosinophilic asthma,
  • Biologic therapy indicated for adults with eosinophilic granulomatosis with polyangiitis,
  • Biologic therapy indicated for patients 12+ with hypereosinophilic syndrome, and
  • Biologic therapy indicated for adults with CRSwNP.

Approximately, two to four percent of the US population is affected by CRSwNP. The disease is characterized by raised eosinophil levels in which nasal polyps develop in the sinuses and nasal cavity. Chronic symptoms of CRSwNP include nasal obstruction, loss of smell, facial pressure, and nasal discharge.

“More than [five] 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, GSK. “GSK is committed to exploring the role of IL-5 inhibition in eosinophil-driven diseases to help address unmet needs of patients.”

The approval of mepolizumab as a treatment for CRSwNP is based on data from the pivotal SYNAPSE study, which explored the effect of mepolizumab vs. placebo in more than 400 patients with CRSwNP.

Source: GSK