CHINA – GlaxoSmithKline plc has unveiled the world’s first biological agent, Benlysta for the treatment of lupus nephritis at the 4th China International Import Expo.

Lupus nephritis is a kidney complication of systemic lupus erythematosus (SLE), an autoimmune disease in which the body’s immune system attacks healthy tissue, affecting the skin, joints, kidneys, brain, and other organs.

Benlysta (Belimumab), the world’s first SLE biologic therapy, has now been approved in China. It is indicated for intravenous (IV) use as add-on therapy in adult patients with active, autoantibody-positive SLE who have high disease activity despite standard therapy.

Belimumab is a human monoclonal antibody administered intravenously that binds to a soluble B lymphocyte stimulator (BLyS). It inhibits B cell proliferation and differentiation, induces apoptosis in autoreactive B cells, and lowers autoantibody levels in the blood, thereby treating SLE.

SLE affects approximately one million people in China, which has the highest incidence in the world.

The injection developed by GSK is the world’s first agent approved for the treatment of SLE and lupus nephritis in adults and children.

Dr Hal Barron, Chief Scientific Officer and President R&D, GlaxoSmithKline (developer of Benlysta) stated: “Active lupus nephritis, which causes inflammation in the kidneys, is one of the most serious consequences of systemic lupus erythematosus and occurs in more than one million patients worldwide. Benlysta is the first biologic approved to treat lupus and lupus nephritis, representing a significant new treatment option for patients and physicians across Europe dealing with this complex autoimmune disease.”

The most common complication of SLE is lupus nephritis, which can lead to kidney failure and necessitate dialysis or a kidney transplant.

In the early stages of SLE, approximately 40 to 60 percent of patients develop lupus nephritis, and approximately 20 percent of patients develop irreversible organ damage, which is the leading cause of death.

Dr Mei Changlin from Shanghai Changzheng Hospital said the current medication and treatment effects for lupus nephritis are both limited in China.

“We hope the biological agent will benefit more patients and help improve clinical effects,” Mei said.

Saphnelo (anifrolumab-fnia) from AstraZeneca has been approved in the United States for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

The third novel agent to enter the SLE/LN market is Aurinia Pharmaceuticals’ Lupkynis (voclosporin), a novel calcineurin inhibitor (CNI) which was approved in January of this year.

It remains to be seen whether these three agents can establish a stronghold ahead of the wave of incoming pipeline agents for SLE and LN.

Olumiant (baricitinib), an Eli Lilly JAK inhibitor, is highly desired by rheumatologists in SLE due to its oral formulation and mechanism of action (MOA) – though the Janus Kinase (JAK) class has recently come under fire due to the results of ORAL Surveillance, which called the class’s safety profile into question.

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