British multinational GlaxoSmithKline announced Wednesday that the U.S. Food and Drug Administration gave its Benlysta (belimumab) the greenlight for use against active lupus nephritis in children aged 5 to 17 on standard therapy.
The FDA’s nod extends Benlysta’s indication in the US, making it the first approved treatment for pediatric lupus nephritis. Benlysta was also the first approved targeted therapy for lupus nephritis in adults in 2011.
“This Benlysta approval highlights GSK’s commitment to bring treatment options to children living with lupus nephritis,” Herson Quinones, VP, specialty and pipeline U.S. medical affairs at GSK, said in a statement.
Lupus nephritis is a common complication of systemic lupus erythematosus (SLE), the most common form of lupus. SLE is an autoimmune disease that turns the immune system against the body causing a wide range of symptoms such as painful joints, rashes and organ damage. Lupus nephritis arises when the immune system attacks the kidney, causing inflammation.
Like SLE, lupus nephritis is chronic and incurable. Often, it can lead to end-stage kidney disease, which can only be eased through dialysis or a transplant. Despite medical advancements over the years, the prognosis for lupus nephritis remains bleak.
This is particularly true in young patients, for whom lupus nephritis means high complications, hospitalizations and death rates. The lack of reliable treatment options worsened the situation: children with lupus nephritis are typically treated with corticosteroids or non-selective immunosuppressants, both of which come with many side effects.
Benlysta is a human monoclonal antibody that targets the B-lymphocyte stimulator, a protein crucial for the growth of B cells, helping to counter the abnormal immune response in lupus patients. The drug is also not a steroid and can be combined with other ongoing lupus medications.
The FDA nod for Benlysta was welcome news to the broader lupus community. “This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life,” Stevan W. Gibson, president and CEO, Lupus Foundation of America, said in a statement.
Kenneth M. Farber, president and CEO of the Lupus Research Alliance, agreed: “Our community has much to celebrate with the approval of the first and much-needed treatment for children with lupus nephritis. We are particularly proud to see belimumab approved to help yet another patient population, having funded much of the original research that led to the drug’s development.”
But despite Benlysta’s success, there remain very few targeted treatment options for lupus nephritis and the drug development pipeline is likewise looking dry. Last month, Kezar Life Sciences announced that its candidate zetomipzomib aced its Phase II trial, inducing an overall response rate in 11 out of the 17 enrolled patients.
Also working on cures for lupus nephritis are Equilium, whose first-in-class monoclonal antibody itolizumab is undergoing Phase Ib assessments, and Vera Therapeutics, which is developing atacicept, a recombinant fusion protein that, like Benlysta, lowers B cell survival.
