- In September 2024, Travere Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted full approval for FILSPARI (sparsentan) to slow the decline in kidney function in adults with primary IgAN who are at risk of disease progression. FILSPARI had previously received accelerated approval in February 2023 based on the surrogate marker of proteinuria. The full approval follows positive long-term confirmatory results from the PROTECT Study, which demonstrated that FILSPARI significantly slowed the decline in kidney function over two years compared to irbesartan.
- In August 2024, Bayer announced the initiation of the ALPINE-1 study, a Phase II clinical trial investigating BAY3283142, an experimental soluble guanylate cyclase (sGC) activator, in patients with chronic kidney disease (CKD). CKD is a progressive condition that impacts over 10% of the global population, affecting around 850 million people worldwide.
- In August 2024, Novartis announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Fabhalta (iptacopan), a first-in-class complement inhibitor, to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of rapid disease progression. This is typically defined by a urine protein-to-creatinine ratio (UPCR) of ≥1.5 g/g. Fabhalta specifically targets the alternative complement pathway of the immune system, which, when excessively activated in the kidneys, is believed to play a role in the development of IgAN.
- In December 2023, Merck announced that the U.S. Food and Drug Administration (FDA) had approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) after they have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
- In September 2023, the U.S. Food and Drug Administration (FDA) granted approval for Jardiance (empagliflozin) 10 mg tablets to help reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease (CKD) who are at risk of progression.
Frequently Asked Questions
Companies such as AstraZeneca (UK), Novartis AG (Switzerland), Sanofi (France), Bristol-Myers Squibb Company (U.S.) and DAIICHI SANKYO COMPANY, LIMITED (Japan), are the major companies in the nephrology drugs market.
In September 2023, the U.S. FDA granted approval for Jardiance (empagliflozin) 10 mg tablets to help reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease (CKD). In December 2023, Merck announced that the U.S. FDA had approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma.
The countries covered in the nephrology drugs market are U.S., Canada and Mexico, Germany, France, U.K., Italy, Russia, Spain, Denmark, Sweden, Norway, Rest of Europe, China, Japan, India, South Korea, Australia, Thailand, Rest of Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Nigeria, Egypt, Kuwait, Rest of Middle East and Africa, Brazil, Argentina and Rest of South America.
