Novartis' oral product Feihe Da®(Iptacopan Hydrochloride Capsules) Approved by the National Medical Products Administration (NMPA) for the Treatment of Adult C3 Glomerulopathy (C3G) to Reduce Proteinuria. Fihada®It is currently the first and only drug that selectively targets the cause of C3G, helping patients effectively control proteinuria and stabilize eGFR (estimated glomerular filtration rate). This is the first renal disease treatment-related indication approved in China since Novartis intensified its efforts in the renal disease treatment field. It is also Fei Heda.®The second indication approved in China after paroxysmal nocturnal hemoglobinuria (PNH).
Ian Li, President and Managing Director of Novartis China, said: "We are very pleased to see Fei Heda®The approval of the C3G indication in China marks a new milestone for Novartis in the field of kidney disease treatment. At the same time, the near-simultaneous approval of the C3G indication in China and the United States also demonstrates Novartis' 'China speed' in accelerating the introduction of innovative drugs, as well as its firm commitment to providing Chinese patients with more treatment options. Starting from this point, Novartis will continue to strengthen its presence in the field of nephrology based on over 40 years of deep understanding and continuous breakthroughs in kidney disease treatment. We will explore more potential treatment solutions and expand the development of new indications to meet the urgent clinical treatment needs of kidney disease patients.
The patient's prognosis is grim, and urgent causal treatment is needed.
C3G is a rare progressive kidney disease. Globally, approximately 1-2 new cases are diagnosed each year per million people.1, and it mostly occurs in young adults, with an average age of diagnosis at only 23.2About 50% of patients will progress to end-stage kidney disease (ESKD) within 10 years, requiring lifelong dialysis treatment or kidney transplantation.2,3However, even after receiving a kidney transplant, 50%-70% of patients will relapse.1。C3G progresses rapidly, and the current limited treatment options and lack of specific drugs targeting the cause have brought significant therapeutic challenges to patients.
"Although C3G is relatively rare, this type of kidney disease progresses rapidly and has a poor prognosis, seriously affecting patients' survival and quality of life. Therefore, early diagnosis and timely causal treatment are particularly crucial.""Professor Minghui Zhao, Director of the Department of Nephrology at Peking University First Hospital and Director of the Peking University Institute of Nephrology, stated""C3G is highly heterogeneous and often difficult to diagnose directly through symptoms. A renal biopsy is required for further clarification. However, since a renal biopsy is an invasive procedure, many patients refuse to undergo it due to concerns or fear, leading to delayed diagnosis and missed optimal treatment opportunities."
Previously, the treatment options for C3G mainly focused on supportive care, immunosuppressive therapy, and symptomatic treatment.4,5, lacking effective treatment methods targeting the cause. "Fei He Da®Approved for the treatment of C3G patients, it undoubtedly fills the current gap in clinical treatment, significantly delaying the progression of kidney disease and improving patients' quality of life."Professor Minghui Zhao added。
Breaking the Treatment Dilemma, Novartis Embarks on a New Layout in the Field of Nephrology
The excessive activation of the alternative pathway (AP) of the complement system is the main pathogenesis of C3G. As a specific oral inhibitor of complement factor B, Fei Heda®Directly targets the primary pathogenic mechanism of C3G, selectively inhibiting the overactivation of the alternative complement pathway (AP) by binding to Factor B, thereby suppressing a series of downstream reactions and the formation of downstream products, ultimately preventing inflammation and kidney damage.
Studies show that Ipkapan can quickly reduce proteinuria and achieve a clinically significant decrease in proteinuria levels.Efficacy observed as early as Day 14, with a 35% significant reduction in proteinuria compared to placebo at 6 months, and sustained eGFR stability at 12 months.6At the same time, Eptinezumab also demonstrated good tolerability and safety in the study, with no patients discontinuing treatment due to adverse events.7。
This approval is of great significance for patients with C3G. By means of an innovative mechanism of action and etiological therapy, it fills the current gap in clinical treatment.Last month, Iptacopan received FDA approval for the treatment of adult C3G, reducing proteinuria. In August 2024, Iptacopan received accelerated FDA approval for reducing proteinuria in adult patients with IgA nephropathy at risk of rapid progression, and the supplemental application for this indication has also been accepted by the National Medical Products Administration.
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