announced they were submitting a new drug application for exenatide, a treatment for type-2 diabetes.
Exenatide is a member of a new class of medication called incretin mimetics and has shown promise reducing blood sugar, helping reduce weight and improving beta cell function in clinical trials.
"The submission of the exenatide NDA is a significant milestone both for Amylin Pharmaceuticals and for our collaboration with Eli Lilly," said Ginger Graham, president and CEO of Amylin Pharmaceuticals. "This NDA includes data on more than 1,800 subjects treated with exenatide. We believe the application provides the FDA with the necessary information to evaluate exenatide for use as a new therapeutic option for people living with type 2 diabetes."
In reaction, Amylin rose 22 cents, or 1%, to $22.42, while Lilly slid 5 cents, or 0.1%, to $70.20.
The clinical data the companies submitted in the NDA come from a series of 30-week studies of the drug in 1,400 people whose blood sugar was unresponsive to a number of common treatments, as well as a yearlong open-label study. After 52 weeks of treatment, patients who took exenatide saw their blood sugar levels, as measured by hemoglobin A1c, fall by 1.1% with an average weight loss of eight pounds.
With more than 174 million people suffering from type-2 diabetes worldwide and an estimated 60% of those not reaching proper blood sugar levels using current treatment options, the race is on to find a drug that can reduce blood sugar without harmful side effects.
Lilly and Amylin aren't alone -- on June 18,
spent $35 million to buy a platform of DP-IV drugs from
of Germany, in hopes of using it as a type-2 treatment.
is also working on a treatment with
called AMG 331.