FDA Committee Votes on Oral T1D Treatment Sotagliflozin
The FDA takes the advice of the panel into consideration when making decisions, however it is not bound by their recommendations.
The FDA takes the advice of the panel into consideration when making decisions, however it is not bound by their recommendations.
“This is the first report of decreased insulin requirements in a patient with T1DM correlating with micafungin administration,” noted the authors.
The NDA included findings from multiple Phase 3 trials evaluating the safety, efficacy, and utility of the Xeris glucagon rescue pen auto-injector to treat severe hypoglycemia vs currently available glucagon emergency kits in children, adolescents, and adults with type 1 diabetes.
The EASE Phase 3 program included 2 double-blind, placebo-controlled trials investigating the efficacy and safety of empagliflozin as an adjunct to insulin therapy in adults with type 1 diabetes.
For this study, researchers conducted a randomized, double-blind, placebo-controlled Phase 2 trial (N=24) to assess the efficacy and safety of adding oral verapamil for 12 months to a standard insulin regimen in adults with recent-onset type 1 diabetes (age range: 18 to 45 years).
Systemic shift in glucose metabolism from oxidative phosphorylation to aerobic glycolysis
The NDA was supported by data from the Phase 3 inTandem clinical trial program which assessed the safety and efficacy of Zynquista in ~3000 adults with inadequately controlled type 1 diabetes.
Increased time in the near normoglycemic range and reduced time in hypo- and hyperglycemia
Sotagliflozin is an investigational dual sodium-glucose co-transporter types 1 and 2 (SGLT1, SGLT2) inhibitor.
Both medications received approval from the FDA in 2017.