The National Institute for Health and Care Excellence (NICE) has reportedly approved GlaxoSmithKline’s (GSK) Benlysta for the treatment of lupus.

Earlier in 2011, NICE rejected Benlysta as it believed that the medicine did not offer value for money.

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

The latest approval will make the drug available for limited use under a managed access scheme between GSK and the National Health Service (NHS) in England, Reuters reported.

NHS will procure the medicine from GSK at an undisclosed discount.

"Benlysta is a prescription medication that is used to treat adults with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines."

NICE will review the treatment after three years, during which additional data on the benefits of the drug will be collected.

Benlysta is a prescription medication that is used to treat adults with active systemic lupus erythematosus (SLE or lupus), who are receiving other lupus medicines.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

It is not known if Benlysta is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus, GSK said in a statement.

Lupus is a disease that occurs when something goes wrong with the immune system.

In a person with lupus, some B cells become autoreactive and such cells produce a type of protein called an autoantibody.

Unlike normal antibodies, which react against foreign invaders like germs, the autoantibodies attack that person’s own body, leading to inflamed body tissue.

Bloomberg previously reported citing GSK that benlysta is already being sold in the US, Germany, Denmark, Sweden, Austria, Norway, Finland and Canada.

Pharmaceutical Technology Excellence Awards - Nominations Closed

Nominations are now closed for the Pharmaceutical Technology Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact.

Excellence in Action
Awarded the 2025 Pharmaceutical Technology Excellence Award for Business Expansion in Integrated Manufacturing, Upperton Pharma Solutions is rapidly expanding its UK GMP and sterile manufacturing footprint. Find out how Upperton’s integrated CDMO model helps pharma companies move from early development to clinical and niche commercial supply with fewer handovers and faster timelines.

Discover the Impact