Glucagon-like peptide-1 (GLP-1) receptor agonists like semaglutide and tirzepatide have cemented their status as two of the most successful drugs in recent memory. Recent projections have estimated that the drug class could fetch $44 billion by 2030 and $71 billion by 2032. But GLP-1 sales could potentially reach greater heights as these therapies move beyond…
Novo Nordisk stops once-weekly semaglutide kidney outcomes trial early following interim analysis
Novo Nordisk will halt the phase 3b FLOW trial, which investigated the effects of once-weekly injectable semaglutide on kidney outcomes in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD). The company reached the decision following the recommendation of the independent Data Monitoring Committee (DMC), following an interim analysis that met pre-specified criteria…
FDA greenlights Jesduvroq, which GSK hails as ‘first innovative medicine’ for anemia in three decades
GSK (NYSE:GSK) has received FDA approval for Jesduvroq, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as a daily treatment for anemia associated with chronic kidney disease in adult dialysis patients. Jesduvroq is the first new medicine for anemia treatment in over 30 years, GSK noted. The drug is the only HIF-PHI to win FDA…
Lilly gets FDA review for empagliflozin in chronic kidney disease
The FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets as a potential therapy to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD). Some 37 million people in the U.S. have CKD. Lilly (NYSE:LLY) is developing the drug with Boehringer Ingelheim. The…
Akebia Therapeutics gets complete response letter from the FDA for vadadustat for CKD-associated anemia
The biopharma Akebia Therapeutics (Nasdaq:AKBA) has received a dreaded complete response letter from FDA for vadadustat, the experimental oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor proposed as a treatment for anemia associated with chronic kidney disease (CKD). A complete response letter communicates the agency’s rejection of an application in its present form. In the case…
Lilly stops Phase 3 Jardiance trial early thanks to clear positive efficacy data
The independent data monitoring committee overseeing the Phase 3 EMPA-KIDNEY trial investigating Lilly’s (NYSE:LLY) Jardiance (empagliflozin) concluded the therapy showed positive efficacy in a formal interim assessment. Boehringer Ingelheim co-developed empagliflozin with Lilly. The EMPA-KIDNEY trial focused on treating adults with chronic kidney disease (CKD). The committee recommended that the Phase 3 study be stopped…
Insilico Medicine AI yields kidney fibrosis drug candidate
Insilico Medicine (Hong Kong) has announced that its AI-enabled drug discovery platform has yielded a preclinical candidate for kidney fibrosis. The company says the preclinical candidate has optimal pharmacological and pharmacokinetic profiles. In addition, it has successfully tested the candidate in both in vitro and in vivo preclinical studies. Insilico Medicine aims to advance the candidate…
FDA to review Akebia’s and Otsuka’s vadadustat for anemia resulting from chronic kidney disease
FDA has accepted a new drug application (NDA) for the oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor vadadustat from Akebia Therapeutics (NSDQ:AKBA) and its partner Otsuka Pharmaceutical Co. (TYO:4578). The two companies are pursuing the use of the drug to treat anemia resulting from chronic kidney disease. The oral drug would offer patients more flexibility…