- After previously rejecting the drug in 2011, U.K.’s cost agency approved GlaxoSmithKline’s lupus drug Benlysta for limited use under a managed access scheme.
- The National Institute for Health and Care Excellence (NICE) uploaded its final determination on Benlysta Tuesday, recommending the National Health Service adopt the drug. Final publication is expected in June.
- Benlysta had been rejected before over efficacy concerns but GSK offered further discounts to clear NICE’s review. And 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 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.
In a statement in November on the trial, Peter Tak, GSK head of the Immuno-Inflammation Therapy Area Unit, said, “This is GSK’s third successful Phase III study of belimumab in patients with lupus, the results of which reinforce our belief in the BLyS pathway as a means of reducing underlying disease activity."
NICE’s recommendation should help the company gain a foothold in the U.K for a drug which has done most of its sales in the U.S.