The European Commission has approved a new subcutaneous formulation of belimumab (Benlysta, GlaxoSmithKline) as adjunctive treatment for adults with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity despite standard therapy.
With initial training by their healthcare provider, patients will be able to administer the new subcutaneous formulation as a once-weekly 200-mg injection from a single-dose prefilled syringe or from a single-dose autoinjector, the company said in a news release.
“The impact of living with lupus forces individuals to adapt their daily personal and working lives in order to manage this complex, chronic disease. With the availability of the IV [intravenous] and subcutaneous formulations of Benlysta, we can now offer patients with SLE and their physicians additional choice, enabling either home or hospital administration of the medicine,” Vlad Hogenhuis, senior vice president of GlaxoSmithKline and head of specialty care, said in the release.
Belimumab is a B-lymphocyte stimulator protein inhibitor that is thought to decrease the amount of abnormal B cells. It is hypothesized that an abnormal B cell count is a mechanism of action in lupus.
The European Medicines Agency (EMA) recommended approval of the self-injectable form of belimumab in September.
The IV formulation of belimumab was first approved in Europe in 2011. Both IV and subcutaneous formulations are also approved in the United States.
Both the US Food and Drug Administration (FDA) and the EMA okayed self-injectable belimumab on the basis of BLISS-SC, a randomized, double-blind, placebo-controlled study involving over 800 patients. The 52-week study found that weekly subcutaneous doses of belimumab 200 mg plus standard SLE therapy reduced disease activity as early as week 16. Patients reported lower levels of fatigue as well. The drug’s safety profile resembled that of the IV form of belimumab.
The efficacy of belimumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, nor has it been studied in combination with other biologics or IV cyclophosphamide. Use of belimumab is not recommended in these situations, the company said.
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