Novartis and Apellis Pharmaceuticals are competing to develop treatments for a rare kidney disease. Both companies have shared promising data about their respective drugs, iptacopan and pegcetacoplan.
Apellis has released results from a late-stage clinical trial showing that pegcetacoplan significantly reduces protein levels in urine, a key indicator of kidney disease, by 68.1% after 24 weeks. This drug, already approved for other conditions, also helps maintain kidney function and reduces harmful protein deposits that can damage the kidneys. Based on these results, Apellis plans to apply for approval of the drug in the U.S. in early 2025 and in Europe later.
Meanwhile, Novartis reported that its drug iptacopan, also known as Fabhalta, reduces protein in urine and improves kidney function over a year. Novartis is moving forward with regulatory applications in Europe, China, and Japan, and plans to apply in the U.S. soon.
Both drugs are generally safe and well-tolerated in trials. Currently, there are no treatments targeting the root cause of the specific kidney diseases Apellis and Novartis are addressing, which affect about 5,000 people in the U.S. and up to 8,000 in Europe. These diseases often lead to kidney failure, requiring transplants or dialysis.
Experts believe these drugs could capture a significant market share due to their effectiveness.