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FDA Agrees to Review New Insulin Glargine Product
NDA filed for long-acting insulin (December 20)
The FDA has accepted a new drug application (NDA) for LY2963016 (Eli Lilly/Boehringer Ingelheim), an investigational basal (long-acting) insulin.
LY2963016 is a new insulin glargine product developed for the treatment of patients with type-1 and type-2 diabetes.
In addition to comparative pharmacokinetic and pharmacodynamic data, the NDA submission includes results from phase III trials that were conducted in patients with type-1 and type-2 diabetes, using a currently marketed insulin glargine product as the active comparator.
Approximately 24.4 million Americans and an estimated 382 million people worldwide have type-1 or type-2 diabetes. Type-2 diabetes is the most common form, accounting for an estimated 85% to 95% of all diabetes cases.
Source: Eli Lilly; December 20, 2013.