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

Ozempic (semaglutide)

Indication:

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

Mechanism:

Glucagon-like peptide-1 (GLP1) agonist.

Dosage:

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:

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.

Reference:

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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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.