Glyxambi Approved for Diabetes
Boehringer Ingelheim and Lilly received approval from the U.S. FDA for the combination product Glyxambi (empagliflozin/linagliptin). Glyxambi is to be used in addition to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) when both empagliflozin and linagliptin are appropriate treatments.
Empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor (marketed in the U.S. as Jardiance), inhibits the reabsorption of glucose in the kidneys, forcing more glucose to be lost in urine. Linagliptin (dipeptidyl peptidase-4 (DPP-4) inhibitor) (marketed in the U.S. as Tradjenta), blocks the enzyme responsible for breaking down the gut hormones glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptides (GIP), both of which play an important role in maintaining blood glucose control.
Glyxambi will be marketed in two fixed-dose empagliflozin/linagliptin combinations: 10mg/5mg and 25mg/5mg tablets.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.