GlaxoSmithKline announced that it received approval for expanded use of Benlysta (belimumab) for lupus nephritis in Europe. The drug is approved for adults in combination with immunosuppressive therapies.
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The approval is based on the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) study. The study showed that Benlysta, combined with standard therapy, increased renal response rates and prevents worsening of kidney disease.
The BLISS-LN is the longest phase 3 study involving 448 adult patients. Primary Efficacy Renal Response (PERR) at two years was considered as a primary endpoint; 43% of patients achieved the primary endpoint versus 32% in patients who were on placebo plus standard therapy. Complete Renal Response at Week 104 and Time to Renal-Related Event or Death were considered as secondary endpoints. Statistically, significant improvement was observed across all the secondary endpoints. Mycophenolate mofetil for induction and maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance, plus steroids were used as standard therapy.
Benlysta was a drug recently approved for lupus nephritis in the US. The drug is a BLyS-specific inhibitor, binds to BLyS, thereby inhibiting the survival of B-cells.