Novartis’ innovative drug Feheta® (Iprokopan Hydrochloride Capsules) is approved for C3G indication in China

Novartis' oral product Feheta ® (ipcopan hydrochloride capsules) has been approved by the National Medical Products Administration (NMPA) for the treatment of C3 glomerulopathy (C3G) in adults to reduce proteinuria. Feheta ® is currently the first and only drug that selectively targets the cause of C3G, which can help patients effectively control proteinuria and stabilize eGFR (estimated glomerular filtration rate). This is the first kidney disease treatment-related indication approved in China since Novartis has stepped up its efforts in the field of kidney disease treatment. It is also the second indication for Feheta® approved in China after paroxysmal nocturnal hemoglobinuria (PNH).

Li Yao, President and Managing Director of Novartis China, said: "We are very pleased to see Feheta® The C3G indication was approved in China, which marks a new milestone for Novartis in the field of kidney disease treatment. At the same time, the C3G indication was approved almost simultaneously in China and the United States, which also demonstrates Novartis's "China speed" in accelerating the introduction of innovative drugs and providing more treatment options for Chinese patients. Firm commitment. Novartis will use this as a starting point, relying on our in-depth understanding and continuous breakthroughs in the treatment of kidney diseases for more than 40 years, to continue to expand its presence in the field of kidney disease, explore more potential treatment options and expand the development of new indications to meet the urgent clinical treatment needs of patients with kidney disease."

The patient's prognosis is dire and urgent treatment is needed

C3G is a rare progressive kidney disease. Globally, approximately 1-2 people per million people are newly diagnosed every year 1 , and it mostly occurs in young adults. The average age of diagnosis is only 23 years old 2 . About 50% of patients will progress to end-stage kidney disease (ESKD) within 10 years, requiring lifelong dialysis treatment or kidney transplantation 2,3 . However, even after kidney transplantation, 50%-70% of patients will relapse 1 . The disease of C3G progresses rapidly. Due to the current limited treatment methods and the lack of specific drugs targeting the cause, it brings great treatment difficulties to patients.

"Although C3G is relatively rare, this type of kidney disease progresses quickly and has a poor prognosis, which seriously affects the patient's survival and quality of life. Therefore, early diagnosis and timely treatment of the cause are particularly critical." said Professor Zhao Minghui, Chief Physician of Peking University First Hospital and Director of the Peking University Institute of Nephrology , "C3G is highly heterogeneous and is often difficult to directly judge through symptoms. Renal biopsy is required to further confirm the diagnosis. However, since renal biopsy is an invasive examination, many patients refuse to accept it due to concerns or fear, resulting in delayed diagnosis and missing the best opportunity for treatment."

Previously, treatment options for C3G mainly focused on supportive treatment, immunosuppressive treatment, and symptomatic treatment 4,5 , and there was a lack of effective treatments targeting the cause. "Feheta® has been approved for the treatment of C3G patients, which undoubtedly fills the gap in clinical treatment at this stage. It will significantly delay the progression of patients' kidney disease and improve their quality of life." Professor Zhao Minghui added.

Breaking the treatment dilemma, Novartis opens a new layout in the field of kidney disease

Excessive activation of the complement alternative pathway (AP) in the immune mechanism is the main pathogenesis of C3G. As a specific oral inhibitor of complement factor B, Feheta ® directly attacks the main pathogenesis of C3G. By binding to factor B, it selectively inhibits the excessive activation of the complement alternative pathway (AP), thereby inhibiting a series of downstream reactions and the formation of downstream products, and ultimately avoiding the resulting inflammation and kidney damage.

Studies have shown that Iprakopan can rapidly reduce proteinuria and achieve clinically meaningful reductions in proteinuria levels. The earliest effect is seen on the 14th day. Proteinuria is significantly reduced by 35% compared with placebo at 6 months, and eGFR remains stable at 12 months 6 . At the same time, Iprakopan also showed good tolerability and safety in the study, and no patient discontinued treatment due to adverse events 7 .

This approval is of great significance to C3G patients. Through innovative mechanisms of action and targeted therapies, it fills the gaps in current clinical treatments. Last month, Iprakopan was approved by the US FDA for the treatment of C3G in adults and the reduction of proteinuria. In August 2024, Iprakopan received accelerated approval from the US FDA for reducing proteinuria in adult patients with IgA nephropathy at risk of rapid progression. The application for expansion of this indication has also been accepted by the National Medical Products Administration.

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