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FDA Approves First Treatment for Pediatric Lupus

MONDAY, April 29, 2019 -- The first treatment has been approved for children with systemic lupus erythematosus (SLE), the U.S. Food and Drug Administration announced Friday.

Benlysta (belimumab) intravenous (IV) infusion was approved for use in adults in 2011. The recent approval in children aged 5 years and older was based on results from the PLUTO (Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy) trial, a 52-week study of 93 children with SLE. Patients received 10 mg/kg IV Benlysta plus standard therapy or placebo plus standard therapy.

A greater proportion of patients receiving Benlysta IV achieved the composite primary end point on the SLE response index compared with patients who received placebo. Patients who received Benlysta IV also had a lower risk for experiencing a severe flare and reached a longer duration without a flare (160 days compared with 82 days with placebo). According to the FDA, the safety and pharmacokinetic profiles of Benlysta IV in children were consistent with those seen in adults with SLE.

Patients who received Benlysta commonly reported experiencing nausea, diarrhea, and fever as well as infusion reactions. The FDA advises clinicians to treat patients with an antihistamine before Benlysta IV. Clinical study data revealed a risk for mortality, serious infections, hypersensitivity, and depression, which are listed in a warning in the doctor and patient information for Benlysta. The FDA says Benlysta should not be administered with live vaccines, and a medication guide should be provided to patients to inform them of the related risks.

Approval of Benlysta was granted to GlaxoSmithKline.

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Posted: April 2019