FDA Accepts Resubmitted Teplizumab BLA for T1D Delay
Teplizumab is an investigational anti-CD3 monoclonal antibody that has been shown to preserve beta cell function, reducing the need for exogenous insulin.
Teplizumab is an investigational anti-CD3 monoclonal antibody that has been shown to preserve beta cell function, reducing the need for exogenous insulin.
Teplizumab is an investigational anti-CD3 monoclonal antibody that has been shown to preserve beta cell function, reducing the need for exogenous insulin.
By scanning the glucose sensor with the app, users will be able to receive their current glucose level, trend arrow, and glucose history.
Teplizumab is an investigational anti-CD3 monoclonal antibody that has been shown to preserve beta cell function, reducing the need for exogenous insulin.
Teplizumab is an investigational anti-CD3 monoclonal antibody.
VX-880 is an investigational allogeneic human stem cell-derived islet cell therapy that may restore pancreatic islet cell function.
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.