FDA Rejects Teplizumab BLA for Type 1 Diabetes
Teplizumab is an investigational anti-CD3 monoclonal antibody that has been shown to preserve beta cell function, reducing the need for exogenous insulin.
Type 1 Diabetes
FDA Panel Votes on Teplizumab for the Delay of Type 1 Diabetes
Teplizumab is an investigational anti-CD3 monoclonal antibody.
Pancreatic Islet Replacement Therapy Fast Tracked for Type 1 Diabetes
VX-880 is an investigational allogeneic human stem cell-derived islet cell therapy that may restore pancreatic islet cell function.
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.
Hypoglycemia Following Antifungal Tx in Patient With Type 1 Diabetes
“This is the first report of decreased insulin requirements in a patient with T1DM correlating with micafungin administration,” noted the authors.
Ready-to-Use Glucagon Rescue Pen Under FDA Review for Severe Hypoglycemia Tx
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.
Positive Results for Empagliflozin in Type 1 Diabetes Trials
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.
Calcium Channel Blocker May Benefit Patients 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).
BCG Vaccine Tied to Reduced Hyperglycemia in Type 1 Diabetes
Systemic shift in glucose metabolism from oxidative phosphorylation to aerobic glycolysis
Oral T1D Treatment Zynquista to Be Reviewed by FDA
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.
