GlaxoSmithKline Benlysta (belyumumab) is recommended and approved by the EU CHMP

GlaxoSmithKline (GSK) recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review suggesting the approval of Benlysta (Chinese trade name: Beliteng, generic name: belimumab, Belyumumab) intravenous and subcutaneous preparations, combined with background immunosuppressive therapy, are used to treat adult patients with active lupus nephritis (LN).

Now, CHMP’s opinions will be submitted to the European Commission (EC) for review, which usually makes a final review decision within 2 months.

LN is one of the most common and serious complications of SLE.

It is worth mentioning that in January 2021, the US FDA approved Aurinia Pharmaceuticals' oral new best-in-class calcineurin inhibitor Lupkynis (voclosporin), combined with a background immunosuppressive treatment plan, for the treatment of adult patients with active LN .

Benlysta was approved for marketing in 2011 and is the first new drug approved for the treatment of SLE in the past 50 years.

In the United States and the European Union, in the treatment of SLE, Benlysta is suitable for the treatment of children and adults with SLE who are receiving standard treatment, aged ≥5 years and positive for active autoantibodies.

For the treatment of adult patients with active LN, Benlysta's regulatory approval from the US FDA and the positive review of the EU CHMP are based on the results of the largest and longest phase III BLISS-LN study in patients with active LN.

The primary endpoint of the study is the primary therapeutic renal response (PERR), which is defined as: glomerular filtration rate (eGFR) ≥60ml/min/1.

The results showed that the study reached the primary endpoint: after 2 years of treatment, compared with the placebo + standard therapy treatment group, the Benlysta + standard therapy treatment group achieved a statistically significant increase in PERR patients (43% vs 32%, odds ratio [ 95%CI]=1.

Systemic lupus erythematosus (SLE) is the most common type of lupus (about 70%), which is a chronic, incurable autoimmune disease, accompanied by a series of symptoms, which over time Fluctuations include joint pain or swelling, extreme fatigue, unexplained fever, skin rash, and organ damage.

Benlysta is the first specific inhibitor of B lymphocyte stimulator (BLyS), which can block the binding of soluble BLyS (a B cell survival factor) to the BLyS receptor on B cells.

Original source: GSK receives CHMP positive opinion recommending approval of Benlysta for adult patients with active lupus nephritis