GlaxoSmithKline's Scores FDA Approval For First IL-5 Inhibitor In Nasal Polyps

The FDA approved GlaxoSmithKline Plc's (NYSE: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.