FDA Approves Benlysta® (Belimumab) for People with Lupus Nephritis

The U.S. Food and Drug Administration (FDA) has approved the use of the drug Benlysta® (belimumab) in people with lupus nephritis. This makes belimumab the first drug approved to treat lupus nephritis.1,2

Benlysta was first approved to treat lupus in 2011. At that time, it was the first drug approved for lupus in 50 years. However, at that time, Benlysta had not been studied for use in people with severe lupus nephritis.1,2

How does belimumab (Benlysta) work?

Belimumab is a monoclonal antibody that targets soluble human B lymphocyte
stimulator proteins (BLyS, or BAFF and TNFSF13B).3

B cells are a type of white blood cell that recognize and fight germs. When a B cell finds what it thinks is a virus, bacteria, or other germs, it creates a protein (BLyS) that attacks and latches onto that foreign invader in order to kill it. In an autoimmune disease like lupus, these B cells mistake healthy cells for invaders.3

Belimumab does not bind B cells directly, but by binding BLyS, the drug limits the survival of reactive B cells, including those that attack healthy tissue. This helps reduce the inflammation caused by lupus.3

Why is this an important approval for people with lupus nephritis?

The approval of Benlysta is especially important because as many as 6 out of 10 people with lupus develop the serious complication lupus nephritis. Of those, up to 1 out of 3 will develop end-stage kidney disease or kidney failure. Having an effective treatment will hopefully improve the lifespan and quality of life of people with lupus nephritis.1,2

Evidence for Benlysta

Benlysta was approved for lupus nephritis after results from the BLISS-LN study were reviewed by the FDA. The BLISS-LN study is the largest, longest phase 3 study ever done in people with lupus nephritis.4

Doctors followed 448 adults with lupus nephritis who took Benlysta for 2 years. Half were given the drug, and half were given a placebo (inactive drug). The study found that the people who had been taking Benlysta had better kidney function and a lower risk of death from kidney failure than people who had taken the placebo.4

What are the possible side effects of Benlysta?

The most common side effects of Benlysta include:3

  • Nausea
  • Diarrhea
  • Fever
  • Stuffy or runny nose
  • Cough
  • Trouble sleeping
  • Depression
  • Headaches
  • Pain or allergic reaction at the injection site

More serious side effects that sometimes occur include:3

  • Infections
  • Chest pain
  • Shortness of breath
  • Suicidal thoughts
  • New or worsening anxiety or depression
  • Allergic reactions such as itching, rashes, dizziness, fainting, swelling of the face, lips, mouth, or throat (anaphylaxis)

These are not all the possible side effects of Benlysta. People taking it should talk to their doctor about what to expect with treatment.

Other lupus nephritis news

In addition to Benlysta’s approval, another drug to treat lupus nephritis, voclosporin, is expected to be approved early in 2021. Voclosporin is being tested in 2 large phase 3 clinical trials, and early results show it is safe and effective.1

For more information, read the full prescribing information of Benlysta.

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