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FDA Gives “Ok” For 1st Treatment For Lupus Pediatric Patients

RM Lupus

The U.S. Food and Drug Administration (FDA) placed their seal of approval on Benlysta (belimumab) intravenous (IV) infusion, a treatment that will help kids who have systemic lupus erythematosus (SLE). This is the first time ever that the organization has okayed a lupus treatment for younger patients. It’s important to note, SLE adult patients have been using Benlysta since 2011.

As per the FDA’s website, the Director for Drug Evaluation and Research, the organization accelerated approval and review of the treatment, as Benlysta IV helps to fill a much-needed void around SLE therapies, especially for child patients suffering from the illness. While lupus cannot be cured, this medicine can assist kids who struggle with lupus gain control over their illness, in hopes it will also help to enhance their quality of living and decrease chances of long-term damage to organs and potential disability.

While SLE is rare in childhood, when it is found, it can be more active in youth and children, versus adult patients; especially when it comes to how the condition impacts the body’s central nervous system and kidneys. Due to the disease diagnosis so early in life, child patients of lupus have an increased risk when it comes to complications from the illness and organ damage, in addition to adverse effects thanks to life-long treatment that is generally needed.

Benlysta IV was reviewed as an effective treatment for pediatric patients suffering from lupus over 52 weeks in 93 young participants. The treatment’s pharmacokinetic and safety profiles within child patients remained consistent with results in SLE adult patients.

Benlysta’s patient and doctor information also has a warning around serious infections, mortality, hypersensitivity, as well as depression, which are based on figures from clinical studies where adult lupus patients were reviewed. It is not recommended for live vaccines to be given with the treatment, and the manufacturer (GlaxoSmithKline) of the treatments needs to offer a Medication Guide to keep patients aware around the risks linked with Benlysta.

Common side effects associated with the treatment include: fever, diarrhea, and nausea. Patients on Benlysta also tend to have infusion reactions, so doctors have been advised to provide patients with an antihistamine prior to treatment.