Lilly, Boehringer fixed-dose diabetes combo could win FDA blessing soon
- Lilly and BI are submitting a fixed-dose combo of empagliflozin and metformin to the FDA for review, with the understanding that each drug has a different mode of action, and that together they may synergistically provide better control of hyperglycemia in patients with diabetes .
- Empagliflozin is marketed as Jardiance in both the U.S. and the EU after receiving approvals in both markets earlier this year.
- Approval of this combo drug would represent a breakthrough since it has the potential to become an oral, one-stop solution for many patients with diabetes.
Jardiance works by removing excess glucose through the urine by blocking glucose reabsorption in the kidneys, while metformin decreases the production of glucose, reduces glucose absorption in the intestines, and improves the body's ability to utilize glucose.
Together, these drugs can not only decrease glucose production, but also remove excess glucose from the body—syngery at its best. An FDA approval is likely, though obviously not guaranteed.
- Pharma Times FDA will review Lilly/BI diabetes combo