FDA grants GSK’s Benlysta orphan drug designation for systemic sclerosis

GSK (NYSE:GSK) announced that FDA has granted Orphan Drug Designation (ODD) to Benlysta (belimumab) for systemic sclerosis (SSc), a rare autoimmune disease that can affect multiple organs.

Interstitial lung disease (ILD) is the leading cause of death in SSc patients.

The monoclonal antibody Benlysta is a B-lymphocyte stimulator (BLyS) specific inhibitor that binds to soluble BLyS. A soluble ligand belonging to the TNF cytokine family, BLyS is elevated in patients with systemic autoimmune diseases such as systemic lupus erythematosus and lupus nephritis. Blocking BLyS decreases the number of abnormal B cells, supporting a reduction in the severity of autoimmune diseases.

GSK shares held steady after announcing the news and Q4 results, dipping 0.20% to $35.19 in mid-day trading.

The company intends to launch a Phase 2/3 study of belimumab for SSc-associated ILD in the first half of 2023.

Benlysta could address an unmet need in systemic sclerosis…
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Chinese regulators approve GSK’s Benlysta for lupus nephritis

GlaxoSmithKline plc (LSE/NYSE:GSK) has announced that China’s National Medical Products Administration (NMPA) has approved Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN), a type of kidney disease affecting more than half of those with systemic lupus erythematosus (SLE).

Benlysta is the only biologic approved to treat SLE and lupus nephritis in China.

The recent indication is constrained to patients receiving standard of care for LN.

The indication for SLE, the most common form of lupus, covers adults and children at least five years old.

FDA approved Benlysta as a lupus treatment in 2011. Approval extended to children at least five years old in 2019. In December 2020, FDA approved an indication of the drug for adults with lupus nephritis.

NMPA approved the new indication after reviewing data from the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) Phase stu…

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