GlaxoSmithKline's Benlysta eyes lupus sales boost after kidney trial win
GlaxoSmithKline has pledged the phase 3 trial to regulators after Benlysta's 2011 approval. (GSK)
GlaxoSmithKline's Benlysta has long enjoyed its place as the sole biologic approved to treat lupus, despite other drugmakers' forays into the field. But with competitors sniffing around, GSK is looking to bring Benlysta into another untried indication—and it could help the drug approach the blockbuster threshold.
After two years, intravenous Benlysta plus standard-of-care induction therapies topped standard of care alone in improving kidney function in trial patients with lupus nephritis—an inflammation of the kidneys caused by the autoimmune disorder. That's a group the drug is not currently cleared to treat.
In a phase 3 study, dubbed Bliss-LN, 43% of lupus nephritis patients in the Benlysta arm achieved primary efficacy renal response—a measure of kidney function—compared with 32% of patients in the control arm. Patients on Benlysta also posted significantly higher response in secondary endpoints, including time to death or a kidney-related complication.
Thanks to a pledge it made to the FDA and the European Medicines Agency after Benlysta's initial approval in 2011, GSK was on the hook for the study, Sheri Mullen, GSK's senior VP of U.S. speciality pharma business, said. The data could make Benlysta the first drug approved to treat lupus nephritis, widening the product's patient pool, and GSK is working "fast and furious" to submit its findings to the FDA in the first half of 2020, she added.
"Our hope is that these data further reassure doctors today that Benlysta has a strong efficacy profile for these patients ... I do hope it reinforces to the community that are very much committed to studying Benlysta across that spectrum," Mullen said.