Zenyaku Kogyo and Chugai’s Rituxan® Gains Approval for Treating Relapsing or Steroid-Dependent Nephrotic Syndrome
Friday, March 28, 2025
Zenyaku Kogyo and Chugai Pharmaceutical have announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an additional indication for the anti-CD20 monoclonal antibody Rituxan® (rituximab).
Nephrotic syndrome is a condition marked by severe protein loss in the urine, leading to widespread swelling due to low levels of albumin in the blood.
It is often caused by damage to the kidney’s glomerular slit diaphragm. Idiopathic nephrotic syndrome, the most common cause of chronic kidney disease in children, is classified as an intractable disease of unknown origin.
Around 80-90% of cases fall under steroid-sensitive nephrotic syndrome, which responds well to steroid treatment. However, approximately half of these cases experience frequent relapses or become dependent on steroids to maintain remission.
Rituxan® is a monoclonal antibody that targets the CD20 protein found on B cells, which play a role in nephrotic syndrome. By eliminating these cells, Rituxan® is believed to help control disease activity.
The approval allows Rituxan® intravenous injection (100 mg and 500 mg) to be used for the treatment of frequently relapsing or steroid-dependent nephrotic syndrome in children, provided the condition has not yet become intractable.
To minimise the side effects associated with long-term steroid use, immunosuppressive drugs are recommended for these patients. However, some individuals do not respond to these treatments and remain dependent on steroids, while others continue to relapse frequently.
There are also concerns regarding serious side effects linked to prolonged use of immunosuppressants.
A clinical trial investigating Rituxan® in children with frequently relapsing or steroid-dependent nephrotic syndrome demonstrated that the treatment significantly prolonged the period without relapse compared to a placebo.
Following these findings, Zenyaku submitted an application for approval in April 2024, which has now been granted.
The companies will continue to collaborate to ensure Rituxan® is accessible to patients with nephrotic syndrome.
Source: chugai-pharm.co.jp
