DOW JONES NEWSWIRES
Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly & Co. (LLY)
are seeking the U.S. Food and Drug Administration's approval to
expand the use of diabetes drug Byetta as an add-on therapy to
basal insulin.
The request comes after the FDA again declined to approve a
long-acting version of Byetta in October, substantially delaying a
widely expected approval.
It was a setback for both companies. The approval is key to the
future of Amylin, which hasn't reported a profit since going public
in 1992, and it was expected to be a positive development for
Lilly, a company working to develop enough new drugs to offset
looming generic competition to its top products.
Wednesday, the companies requested Byetta be considered as an
add-on therapy to basal insulin, sometimes explained as "background
insulin," regardless of the use of other diabetes drugs metformin
and thiazolidinedione and in conjunction with diet and
exercise.
Amylin Chief Medical Officer Orville G. Kolterman said many
patients using basal insulin, with or without oral diabetes
medications, have trouble maintaining adequate blood-sugar control,
especially at mealtime.
"If approved for this expanded use, Byetta may provide a
complementary addition to basal insulin to improve overall blood
sugar control with no weight gain and no increased risk of
hypoglycemia," he said, adding the combination may also offer a
mealtime treatment option that needs to be taken only twice a day
and doesn't need dosage adjustments.
Amylin shares were up 1.2% at $15.39 after hours, while Eli
Lilly's were down 0.2% at $35.39.
-By Joan E. Solsman, Dow Jones Newswires; 212-416-2291;
joan.solsman@dowjones.com