Category: active

• The approval follows BTD and PR & is based on P-lll BLISS-LN study involves assessing Benlysta (IV, 10 mg/kg) + SOC vs PBO + SOC in 448 adult patients with active LN
• The study met its 1EPs demonstrating a greater number of patients who achieved PERR @2yrs. (43% vs 32%., all 2EPs were achieved while safety results are consistent with the known safety profile of Benlysta
• Benlysta is a mAb that binds to soluble BLyS and does not bind B cells directly. The approval extends the current indication in the US to include both SLE and LN for both the IV and SC formulations

Click here ­to­ read full press release/ article | Ref: GSK | Image: Euronews

The post GSK’s Benlysta (belimumab) Receives the US FDA’s Approval as the First Therapy for Active Lupus Nephritis (LN) first appeared on PharmaShots.

Shots:

• In the HIBISCUS I induction study, in patients without prior anti-TNF treatment, etrolizumab met its 1EPs while in HIBISCUS II study in the same kind of people, it did not meet its 1EPs. In the HICKORY study, in patients with prior anti-TNF treatment, therapy met its 1EPs at induction but not at maintenance
• In the LAUREL maintenance study in people without prior anti-TNF treatment, etrolizumab failed to meet its 1EPs while the safety profile of therapy was consistent with previous studies and no major safety issues were reported till date in the four P-III studies
• The therapy is currently being evaluated as an induction/maintenance treatment in people with mod. to sev. active CD with/out prior anti-TNF treatment in a global P-III study (BERGAMOT) and OLE and safety monitoring study (JUNIPER), involving 1,100+ people with CD. In addition, Roche is studying other therapies in IBD and is committed to further understanding this disease

Click here ­to­ read full press release/ article | Ref: Roche | Image: Pantone Canvas Gallery

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