The European Commission approved mepolizumab as an add-on treatment in three additional eosinophil-driven diseases: hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, and chronic rhinosinusitis with nasal polyps.
The authorization follows positive opinions for mepolizumab in the three indications by the Committee for Medicinal Products for Human Uses in September.
During a 32-week study of patients with hypereosinophilic syndrome (HES), 28% of patients had an HES flare when treated with mepolizumab versus 56% with placebo (P = 0.002), according to a press release from the manufacturer.
When added to standard of care in eosinophilic granulomatosis with polyangiitis (EGPA), mepolizumab increased accrued time in remission and proportion of patients achieving remission compared with placebo.
For adults with CRSwNP and at least one prior surgery, 70% of whom had a diagnosis of asthma; mepolizumab significantly improved the size of nasal polyps and nasal obstruction when added to standard of care, compared to placebo, according to the release.
The release noted the treatment “is the first approved targeted treatment for EGPA and the first anti-IL-5 biologic treatment for patients with HES or CRSwNP in Europe.”
Mepolizumab is also currently approved as an add-on treatment for patients 6 years and older with severe eosinophilic asthma.
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