Novartis’s Fabhalta is the first FDA-approved therapy for C3 glomerulopathy. But Apellis Pharmaceuticals’ Empaveli has superior clinical data, and that drug has been submitted for FDA review in the same rare kidney disease as well as another one that does not yet have an approved therapy.
Novartis drug iptacopan, which won its first FDA approval in early December in a rare blood disorder, has met the main goal of a pivotal test in an ultra-rare kidney disease. The small molecule’s potential to address many diseases has stirred up blockbuster expectations.
Across the nation, state-based health insurance exchanges are searching for ways to better serve their communities while making enrollment easier, more personal, and more accessible for everyone.
The company said in its 2Q earnings that it would halt development of ALXN2040 for C3 glomerulopathy, or C3G, citing the drug's lack of potency. However, it may develop a second, more potent drug from the Achillion acquisition, ALXN2050, in the same disease.