GSK’s lupus treatment receives FDA approval for treating pediatric patients

Benlysta (belimumab) from Glaxo-Smith Kline was previously approved in 2011​ by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the intravenous administration in adults with systemic lupus erythematosus (SLE) – the recent approval from the FDA extends the indication to children five years and above.

With the approval of the extended indication, Benlysta is the only medicine approved in the US for both adults and children with SLE.

Benlysta is a BLyS-specific inhibitor human monoclonal antibody (mAb) that binds to soluble BLyS to inhibit the survival of B cells, including autoreactive B cells.

A spokesperson for GSK told us, “One of the outstanding issues for the management of lupus is the need for new effective treatments for children.”​

They continued, “The FDA’s approval of Benlysta for children with SLE, which is the most common and serious form of lupus, is significant since no pediatric medicines specifically approved for SLE have existed on the market until now.” ​

SLE is a chronic autoimmune disease that can cause painful or swollen joints, extreme fatigue, unexplained fever, skin rashes, and organ damage. GSK states that approximately 5 million people have lupus worldwide.
Children with SLE often have a more active disease, according to GSK, and the disease in children is associated with more rapid accrual of damage and a higher degree of morbidity than in adult populations.

The extended approval comes after the supplemental biologics license application (sBLA), designated priority review by the FDA, demonstrated data from a post-approval commitment study assessing the efficacy, safety, and pharmacokinetics of the drug in children aged 5-11 years and 12-17.

The GSK spokesperson stated that there are an estimated 5,000-10,000 pediatric patients living with SLE in the US and between 32-63% of these patients may be suitable to receive Benlysta.

The IV formulation of the drug is not approved for use in children anywhere else in the world; however, regulatory submissions are ongoing.

In 2017, GSK expanded one of its manufacturing plants in Rockville, Maryland, to accommodate the growing US demand for Benlysta.​ The company spent $139m (€127m) to increase the active pharmaceutical ingredient (API) manufacturing capacity at the facility by more than 50%.

Benlysta was originally developed by Human Genome Sciences, which GSK acquired in 2012 for $3.6bn​.