FDA approvals

2017 GLP-1 FDA approvals & regulatory actions

3 regulatory events affecting GLP-1 medications in 2017.

December 5, 2017Original approval
Ozempic
Once-weekly semaglutide injection approved for type 2 diabetes. SUSTAIN trial program showed superior A1C and weight reduction vs comparators.
Read on fda.gov →
October 20, 2017Original approval
Bydureon BCise
BCise autoinjector formulation approved — improved once-weekly exenatide delivery with single-use autoinjector.
Read on fda.gov →
August 25, 2017New indication
Victoza
FDA approved Victoza for reducing risk of major adverse cardiovascular events (MACE) in adults with T2D and established CV disease (LEADER trial).
Read on fda.gov →

FDA approvals

3 regulatory events affecting GLP-1 medications in 2017.

December 5, 2017Original approval
Ozempic
Once-weekly semaglutide injection approved for type 2 diabetes. SUSTAIN trial program showed superior A1C and weight reduction vs comparators.
Read on fda.gov →
October 20, 2017Original approval
Bydureon BCise
BCise autoinjector formulation approved — improved once-weekly exenatide delivery with single-use autoinjector.
Read on fda.gov →
August 25, 2017New indication
Victoza
FDA approved Victoza for reducing risk of major adverse cardiovascular events (MACE) in adults with T2D and established CV disease (LEADER trial).
Read on fda.gov →

Ozempic