18th Dec 2019 15:49
(Alliance News) - GlaxoSmithKline PLC said Wednesday the headline results for the phase 3 study of Benlysta were "positive", with regulatory submission scheduled for next year.
The study, GSK said, met its primary endpoint, and all major secondary endpoints.
"The efficacy and safety of Benlysta/Belimumab in patients with active lupus nephritis study, involving 448 patients, met its primary endpoint demonstrating that a statistically significant greater number of patients achieved primary efficacy renal response over two years when treated with belimumab plus standard therapy compared to placebo plus standard therapy in adults with active lupus nephritis," the pharma firm explained.
The drug also demonstrated "statistical significance" compared to placebo across its four major secondary endpoints.
GSK Chief Scientific Officer & President R&D Hal Barron said: "Lupus nephritis is one of the most common and serious complications of SLE, occurring in up to 60% of adult patients. The results of the BLISS-LN study show that Benlysta could make a clinically meaningful improvement to the lives of these patients who currently have limited treatment options."
GSK said Benlysta is on track for regulatory submission in the first half of 2020. Benlysta is currently not recommended for use in severe active lupus nephritis anywhere in the world because it has not been previously evaluated in patients.
Shares in GlaxoSmithKline were 0.7% higher in London on Wednesday afternoon at 1,790.20 pence each.
By Paul McGowan; [email protected]
Copyright 2019 Alliance News Limited. All Rights Reserved.
Related Shares:
Glaxosmithkline