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 advisory committee recommends not approving FibroGen’s anemia drug candidate roxadustat
The FDA’s independent Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted against approving Roxadustat from FibroGen, which would be a novel treatment of anemia resulting from chronic kidney disease (CKD). Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. FibroGen’s CEO said in a statement that the company believes scientific evidence warrants approval of…
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…