hohl Novartis ( NYSE: NVS ) reported interim results from a Phase 3 study of its drug candidate astrasentan in the treatment of IgA nephropathy, a rare type of kidney disease. The Swiss drugmaker said the study showed a statistically significant 36.1% reduction in proteinuria, or protein in the urine, at 36 weeks in patients who received the treatment on top of supportive care versus those who received a placebo along with supportive care.
Novartis said reduction in proteinuria is recognized as a surrogate marker correlating with delaying the progression of kidney failure. The company has used reduction in proteinuria as an endpoint in the IgA nephropathy clinical trials to support accelerated regulatory approval. Novartis added it was on track to file for FDA approval in the first half of 2024.
A final analysis of the study, called ALIGN, is expected in 2026. More on Novartis Novartis: Buy This Blue-Chip Dividend Stock On Sale Now Novartis AG (NVS) Q1 2024 Earnings Call Transcript Novartis: Strong Start To The Year With Beat-And-Raise First Quarter Results ADHD diagnoses increasing, becoming an 'expanding public health concern': CDC MorphoSys gains after Novartis discloses all tender offer conditions were met.
