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

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/PeopleImages)
(Image: Getty/PeopleImages)

Related tags: Gsk, Fda, Lupus, Pediatrics, Monoclonal antibody, Us

The US FDA approves an extended indication of GSK’s lupus treatment, Benlysta IV, for children five years and older, giving pediatric patients a new therapeutic option.

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​.

Related news

Show more

Related products

show more

rAAV Production in BioBLU® Single-Use Vessels

rAAV Production in BioBLU® Single-Use Vessels

Eppendorf for Bioprocess – Solutions that grow with you | 25-Jun-2019 | Application Note

Rising interest in gene therapy-based applications leads to increasing demands in scalable production systems for viral vectors. Find out how Cevec Pharmaceuticals...

Small-Scale Cell Culture Perfusion Process

Small-Scale Cell Culture Perfusion Process

Eppendorf for Bioprocess – Solutions that grow with you | 29-Mar-2019 | Application Note

Perfusion cell culture processes promise advantages for industrial bioprocessing, like saving space, increasing volumetric productivity, achieving more...

Cultivation of 3D Cell Aggregates in Perfusion

Cultivation of 3D Cell Aggregates in Perfusion

Eppendorf for Bioprocess – Solutions that grow with you | 17-Sep-2018 | Application Note

3D cell aggregates are of great interest for applications like disease modeling and manufacturing of stem cell-based products. Read more about the cultivation...

Nifty Biosimilar

Nifty Biosimilar

UGA Biopharma | 13-Mar-2018 | Research Study

Aflibercept (Zaltrap®) is a recombinant fusion protein with complex post-translational modifications. Therefore deep understanding of biosimilar development...

Related suppliers

Follow us

Products

View more

Webinars