The approval was based on data from the phase 3b SUSTAIN FORTE trial, which compared Ozempic 2mg to 1mg in adults with type 2 diabetes.
The Food and Drug Administration (FDA) has approved a 2mg dose of Ozempic® (semaglutide) injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of major cardiovascular events (eg, heart attack, stroke, or death) in adults with type 2 diabetes and known heart disease.
The new 2mg dose of Ozempic will be supplied as 8mg/3mL (2.68mg/mL) of semaglutide in a single-patient-use pen delivering 4 doses of 2mg per injection. Previously, Ozempic was available as a single-patient-use pen delivering 0.25mg, 0.5mg, or 1mg per injection with a maximum recommended dosage of 1mg weekly.
The approval was based on data from the phase 3b SUSTAIN FORTE trial (ClinicalTrials.gov Identifier: NCT03989232), which compared semaglutide 2mg to 1mg in adults with type 2 diabetes. Patients received 1 injection per week during the 12-week dose escalation period until the target dose of 2mg or 1mg was achieved and continued on the therapeutic dose from week 13 to week 40.
Findings showed that among patients with an elevated mean baseline A1C of 8.9%, treatment with semaglutide 2mg resulted in a statistically significant and superior 2.1% reduction in A1C at week 40 compared with a 1.9% reduction with semaglutide 1mg (P <.01). Additionally, among patients with a mean baseline body weight of 219lb, treatment with semaglutide 2mg led to a weight reduction of 14.1lb vs 12.5lb with semaglutide 1mg; the difference was not found to be statistically significant.
“With a 2mg dose, we have an additional option so patients can stay on the same medication therapy even if their blood sugar needs shift,” said Dr Juan Pablo Frias, medical director of Velocity Clinical Research, Los Angeles and principal investigator of SUSTAIN FORTE.
The safety profile for semaglutide 2mg was similar to that observed with the 1mg dose. The most common adverse reactions included gastrointestinal events (eg, nausea, diarrhea, and vomiting), which occurred at a higher frequency in the 2mg group (34%) compared with the 1mg group (30.8%).
The Company expects to launch Ozempic 2mg shortly.
