Novartis' Hydrochloride Ipilimumab Capsule Approved for C3G in China, Reduces Proteinuria by 35%

Novartis (NVS.US) has announced that its hydrochloride ipilimumab capsule has received approval from China's National Medical Products Administration (NMPA) for a new indication. The drug is now approved for the treatment of adult C3 glomerulopathy (C3G) to reduce proteinuria. This marks the second indication approved for the product in China, following its initial approval in April 2024 for another condition.

The approval of this new indication is a significant milestone for Novartis, as it expands the therapeutic options available for patients suffering from C3G. C3G is a rare and severe kidney disease characterized by the deposition of complement component 3 (C3) in the glomeruli, leading to proteinuria and potential kidney failure. The approval of hydrochloride ipilimumab capsule for this indication provides a much-needed treatment option for patients who previously had limited therapeutic choices.

The decision by the NMPA to approve this new indication is based on clinical trial data that demonstrated the efficacy and safety of hydrochloride ipilimumab capsule in reducing proteinuria in adult patients with C3G. The clinical trials showed that the drug was well-tolerated and effectively reduced proteinuria, which is a critical marker of kidney function and disease progression. The drug was able to rapidly lower proteinuria, achieving clinically significant reductions in proteinuria levels as early as the 14th day. After six months, proteinuria levels were significantly reduced by 35% compared to the placebo, and the estimated glomerular filtration rate (eGFR) remained stable for 12 months.

This approval not only benefits patients in China but also underscores Novartis' commitment to innovation and its focus on developing therapies for rare and severe diseases. The company has a strong track record of bringing innovative treatments to market, and this latest approval further solidifies its position as a leader in the pharmaceutical industry. The expansion of hydrochloride ipilimumab capsule's indications in China is a testament to Novartis' dedication to improving patient outcomes and addressing unmet medical needs. The company continues to invest in research and development to discover and develop new therapies that can make a meaningful difference in the lives of patients.