GlaxoSmithKline’s antibody drug Nucala may not have been the first biologic approved in nasal polyps—that distinction goes to Sanofi and Regeneron’s Dupixent. But on Thursday, it did become the first IL-5 inhibitor to break into the indication, notching a win over AstraZeneca’s would-be rival Fasenra.
The FDA gave Nucala the green light to treat chronic rhinosinusitis with nasal polyps (CRSwNP). The monoclonal antibody, which also goes by the name mepolizumab, was approved as an add-on maintenance therapy for adults who aren’t getting enough help from nasal corticosteroids, GSK said in a release.
The approval marks Nucala’s fourth in eosinophilic-driven diseases and adds another weapon to the biologics arsenal for the 2% to 4% of Americans—or more than 5 million people—who suffer from nasal polyps.
Nucala is hitting the market behind Sanofi and Regeneron’s immunology superstar Dupixent, which bagged its nasal polyps nod in mid-2019. As the first IL-5 drug approved in the disease, though, Nucala has further cemented its lead over Fasenra, which recently lagged GSK’s drug for an approval in hypereosinophilic syndrome (HES), too.
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The FDA based its approval on results from the phase 3 SYNAPSE study, which pitted Nucala against placebo in more than 400 patients with CRSwNP. All patients in the study received standard care and previously had surgeries for their polyps, with roughly a third having undergone more than three surgeries, GSK said. The SYNAPSE subjects were also in need of additional operations because of their symptom severity and the increased size of their polyps, the company added.
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. Crucially, the drug also cut the size of nasal polyps and nasal obstruction over the 52-week period.
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Elsewhere on the eosinophilic front, Nucala is approved in kids and adults with severe asthma that has an eosinophilic phenotype plus the rare disease eosinophilic granulomatosis with polyangiitis and the rare white blood cell disease HES. It was the first biologic to win FDA approval in the latter two, GSK pointed out. The drug broke the blockbuster barrier last year with £994 million ($1.38 billion) in sales, according to the company’s annual report (PDF).
AstraZeneca’s drug, for its part, reeled in (PDF) $949 million in full-year 2020 sales. In September, the company announced phase 3 data showing the drug plus standard steroids significantly reduced the size of nasal polyps and the severity of nasal blockage in CRSwNP patients.
Meanwhile, Nucala and Fasenra have been duking it out in rare eosinophilic asthma for the past several years.