GSK Receives Positive Opinion from CHMP for Nucala

GlaxoSmithKline (GSK) has received a positive recommendation from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) for Nucala (mepolizumab) to be used as a treatment in three additional eosinophil-driven diseases.

According to a Sep. 17, 2021 press release, the three positive opinions have been based on data from pivotal studies investigating the role of targeted interleukin-5 (IL-5) inhibition with mepolizumab in hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA), and chronic rhinosinusitis with nasal polyps (CRSwNP). The CHMP’s recommendation will be put forward to the European Commission for final consideration of marketing authorization.

“We are pleased with the CHMP’s positive opinions as there are currently limited targeted treatment options available for patients in Europe with eosinophil-driven disease,” said Christopher Corsico, senior vice-president development, GSK, in the press release. “If approved, mepolizumab would be the first targeted treatment available for use in four of these diseases and would further reinforce its role in targeting the underlying cause of inflammation.”