Benzinga | Jul 30, 2021 07:51AM EDT

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.