After previously rejecting the drug in 2011, NICE ( National Institute for Health and Care Excellence ) has approved lupus drug Benlysta ( Belimumab ) for limited use under a managed access scheme.
NICE uploaded its final determination on Benlysta, recommending the National Health Service ( NHS ) adopt the drug.
Benlysta had been rejected before over efficacy concerns. The current approval requires another review of outcomes data after three years.
The standard of care for treatment of lupus is either glucocorticoids, immunosuppressants, or some combination of both. But each treatment has significant drawbacks over the long term.
As the first new treatment approved for lupus in more than 50 years, Benlysta represents a new approach to managing the difficult-to-control disease.
Benlysta is designed to block B-lymphocyte stimulators in order to prevent production of autoantibodies, one of the main hallmarks of the disease.
Currently, GSK ( GlaxoSmithKline ) is testing a subcutaneous version of Benlysta in phase 3 trials.
According to recent results from the Bliss-SC trial, patients treated with Benlysta had significantly better outcomes on the Systemic Lupus Erythematosus Responder Index ( SRI ) at week 52, compared with standard of care patients ( 60% vs. 48.47% ).
Also, patients who took Benlysta experienced fewer flare-ups and were more likely to be able to decrease or stop usage of corticosteroids compared with standard-of-care patients.
Systemic lupus erithematosus ( SLE ) is the most common form of lupus, affecting approximately 70% of an estimated 5 million people with lupus worldwide.
SLE is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage. ( Xagena )
Source: GSK, 2016