FDA Approves First Treatment for Paediatric Patients With Lupus

The US Food and Drug Administration (FDA) has approved belimumab (Benlysta) intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (SLE).

This is the first time that the FDA has approved a treatment for paediatric patients with SLE.

Belimumab has been approved for use in adult patients since 2011.

"The agency expedited the review and approval of this application because belimumab IV fulfils an unmet need for therapies, specifically in paediatric patients with SLE," said Janet Woodcock, MD, FDA Center for Drug Evaluation and Research, Rockville, Maryland. "While there is no cure for lupus, treatment can help our youngest patients control their disease with the hope of improving their quality of life and lowering their risk of long-term organ damage and disability."

While childhood-onset SLE is rare, when diagnosed, it is generally more active in children and adolescents than in adult patients, particularly in how it impacts organs such as the kidneys and central nervous system. As a result of the disease starting early in life, paediatric patients with SLE are at a higher risk for developing increased organ damage and complications from the disease as well as adverse events from the lifelong treatments usually required.

The efficacy of belimumab IV for the treatment of SLE in paediatric patients was studied over 52 weeks in 93 children with SLE. The proportion of paediatric patients achieving the composite primary endpoint, the SLE response index (SRI-4), was higher in children receiving belimumab IV plus standard therapy compared with placebo plus standard therapy.

Pediatric patients who received belimumab IV plus standard therapy also had a lower risk of experiencing a severe flare, as well as longer duration of time until a severe flare occurred (160 days vs 82 days).

The drug's safety and pharmacokinetic profiles in paediatric patients were consistent with those in adults with SLE.

The doctor and patient information for belimumab includes a warning for mortality, serious infections, hypersensitivity, and depression, based on data from clinical studies in adults with SLE.

The drug should not be administered with live vaccines.

The manufacturer is required to provide a Medication Guide to inform patients of the risks associated with belimumab.

The most common side effects of belimumab include nausea, diarrhoea, and fever. Patients also commonly experienced infusion reactions, so healthcare professionals are advised to pre-treat patients with an antihistamine.

SOURCE: US Food and Drug Administration

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Benjamin Hidalgo-Matlock
Skin Care Physicians of Costa Rica

Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574

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