FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD


January 11, 2018

In This Article

Ozempic (semaglutide)


Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.


Glucagon-like peptide-1 (GLP1) agonist.


0.25 mg SC once weekly for 4 weeks, then increase dose to 0.5 mg once weekly. If glycemic control is not achieved after at least 4 weeks on 0.5-mg dose, the dose may be increased to 1 mg once weekly.


Approval was based on 8 phase 3a studies (the SUSTAIN trials). Moreover, in the SUSTAIN-6 study, the cardiovascular outcomes trial, the drug was found to contribute to cardiovascular risk reduction.


Marso SP, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-44.


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