- The FDA approved GlaxoSmithKline Plc's GSK Nucala (mepolizumab) for chronic rhinosinusitis with nasal polyps, making it the first IL-5 inhibitor to break into the indication.
- The approval comes as an add-on maintenance therapy for adults with inadequate response to nasal corticosteroids.
- The approval marks Nucala's fourth in eosinophilic-driven diseases.
- The FDA based its approval on results from the phase 3 SYNAPSE study, which pitted Nucala against placebo in more than 400 patients.
- In the 52-week trial, 57% fewer patients on Nucala needed surgery versus those in the placebo arm, GSK noted. Fewer patients on Nucala needed systemic corticosteroids, too.
- The drug also cut the size of nasal polyps and nasal obstruction over the 52 weeks.
- Price Action: GSK shares are down 0.5% at $39.92 during the market session on the last check Friday.
- Related content: Benzinga's Full FDA Calendar.
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