Endocrine Today has compiled a list of recent news reports about diabetes drugs, including FDA actions and new agents in development.
FDA advisory committee splits vote recommending dual SGLT inhibitor for 1 diabetes
The Endocrinologic and Metabolic Drugs Advisory Committee voted 8-8 in a decision on whether to recommend approval of a new drug application for oral sotagliflozin, a first-in-class dual SGLT1 and SGLT2 inhibitor for type 1 diabetes, with several members expressing concerns about an observed risk in diabetic ketoacidosis and calling for a risk evaluation and mitigation strategy if the therapy is approved.
No urinary tract infection risk with most SGLT2 inhibitors
SGLT2 inhibitors do not increase the risk for urinary tract infections in people with type 2 diabetes; however, high doses of dapagliflozin may be an exception, according to findings published in CMAJ Open.
FDA committee narrowly supports continued CV outcomes trials for diabetes drugs
An FDA advisory committee voted 10-9 in favor of supporting continued agency-recommended cardiovascular outcomes trials to demonstrate safety for all type 2 diabetes drugs, with most committee members recommending modifications to the 2008 guidance after a decade of data and no indication of increased CV risk.
Novel drug combination induces human beta-cell regeneration
A novel combination of two distinct classes of molecules has been shown to induce proliferation in adult human beta cells at a rate of 5% to 8% in in vitro and 2% in in vivo transplant models, a rate far exceeding pancreatic beta-cell replication rates from other experimental drugs, according to findings published in Cell Metabolism.
Sandoz, Gan & Lee enter agreement to market insulin biosimilars
The agreement covers biosimilar insulins in early and clinical development for the European Union and the United States for the top three selling branded insulins by sales: glargine (Lantus, Sanofi), lispro (Humalog, Eli Lilly) and aspart (NovoLog, Novo Nordisk). Sandoz, which currently has eight marketed biosimilars, is a division of Novartis Group.