BENLYSTA (belimumab) - Systemic lupus erythematosus (SLE)

The clinical benefit of BENLYSTA 200 mg (belimumab) solution for injection in pre-filled pen is substantial in the MA indication.

Considering:

• the inadequately met medical need;
• the efficacy data in adults, which can be extrapolated to children based on similar pharmaco-kinetic data in adults and children for the intravenous route;
• the absence of data in patients with severe neurological involvement, despite this being an important prognostic factor in the course of juvenile SLE;
• the absence of robust data on quality of life;
• the short-term safety profile (follow-up of 1 year) globally similar to that in adults, but with concerns relating to the long-term safety in children due to important identified risks, such as injection-related systemic hypersensitivity reactions that may be delayed in onset, and important potential risks such as serious infections (in particular, progressive multifocal leuko-encephalopathy), malignancies and psychiatric disorders (depression and suicidal behaviour);
• the absence of data on the growth and development of children;

the Committee considers that, as is the case in adults, the proprietary medicinal products BENLYSTA 120 mg and 400 mg (belimumab) powder for concentrate for solution for infusion provide a minor clinical added value (CAV IV) in the care pathway as add-on therapy in children aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy.