GSK gets USFDA nod for Benlysta to treat pediatric patients with lupus

New Delhi: GlaxoSmithKline (GSK) has won the US Food and Drug Administration's (USFDA) approval for its Benlysta (belimumab) intravenous (IV) infusion to treat children with systemic lupus erythematosus (SLE). Benlysta (belimumab) intravenous (IV) infusion is suggestive for the treatment of children with systemic lupus erythematosus (SLE), often referred to as simply "lupus", a serious chronic disease that causes inflammation and damage to various body tissues and organs.

This is the first time that the FDA has approved a treatment for pediatric patients with SLE. Benlysta has been approved for use in adult patients since 2011.

Commenting on the same, Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research said, "The agency expedited the review and approval of this application because Benlysta IV fulfils an unmet need for therapies, specifically in pediatric patients with SLE. 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."

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

While childhood-onset SLE is rare, when diagnosed, it is generally more active in children and adolescents than 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, pediatric 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 life-long treatments usually required.

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Pediatric patients who received Benlysta 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 (160 days versus 82 days). The drug's safety and pharmacokinetic profiles in pediatric patients were consistent with those in adults with SLE.

Benlysta's doctor and patient information include a warning for mortality, serious infections, hypersensitivity and depression, based on data from the 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 Benlysta.

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

The FDA granted this application a Priority Review designation. The FDA granted the approval of Benlysta to GlaxoSmithKline.