Chugai Pharmaceutical and Nippon Shinyaku have announced that Chugai filed a regulatory application with the Ministry of Health, Labour and Welfare (MHLW) for the anti-cancer agent/humanised anti-CD20 monoclonal antibody Gazyva for Intravenous Infusion 1000 mg [generic name: obinutuzumab (genetical recombination)] for an additional indication of Idiopathic Nephrotic Syndrome (INS).

“Idiopathic Nephrotic Syndrome often develops during childhood and is characterised by repeated relapses. As a result, adverse effects associated with the long-term use of steroids and immunosuppressants remain a significant challenge, affecting patients’ daily lives and future.

Dr. Osamu Okuda, President and CEO, Chugai, said, “In the INShore study, the Gazyva plus oral steroid treatment group demonstrated the potential to reduce patients’ treatment burden through sustained remission and steroid reduction compared with conventional therapy. We will continue our efforts toward regulatory approval so that this new treatment option can be delivered to patients as soon as possible.”

The filing is based on results from the INShore study, a global, multicenter, randomised, open-label phase 3 clinical trial evaluating the efficacy and safety of Gazyva in patients with INS.

Toru Nakai, President, Nippon Shinyaku, said, “We are very pleased to have reached the stage of submitting an application for approval of Gazyva for a new indication, Idiopathic Nephrotic Syndrome. We believe that the addition of this indication for Gazyva will help meet unmet needs in clinical practice and further contribute to the treatment of patients.”