FDA approves higher-dose Ozempic 2 mg pen for type 2 diabetes

The FDA approved a 2 mg dose of Ozempic (semaglutide) on March 28, 2022, giving adults with type 2 diabetes a higher-strength option than the 0.5 mg and 1 mg doses that were already available ^[1].

Novo Nordisk, which makes Ozempic, said the approval provides increased glycemic control for adults with type 2 diabetes ^[1]. Ozempic is a GLP-1 receptor agonist given as a once-weekly subcutaneous injection in the abdomen, thigh or upper arm, at any time of day, with or without meals ^[2]. The drug was first approved on December 5, 2017 ^[1][3].

Before this action, the Ozempic pen delivered 0.25 mg, 0.5 mg or 1 mg per injection ^[2]. The 2 mg dose comes in an 8 mg/3 mL (2.68 mg/mL) pen that holds four doses of 2 mg ^[2]. The label describes a stepwise schedule: treatment starts at 0.25 mg once weekly, rises to 0.5 mg once weekly after four weeks, and can move to 1 mg once weekly after at least four more weeks if more blood sugar control is needed. The 2 mg dose can follow after at least four weeks at 1 mg ^[2]. Reaching 2 mg therefore takes at least 12 weeks under the schedule described in the label.

Common side effects reported in at least 5 percent of patients taking the Ozempic injection are nausea, vomiting, diarrhea, abdominal pain and constipation ^[2]. The label carries a boxed warning that semaglutide causes thyroid C-cell tumors in rodents and that it is unknown whether Ozempic causes these tumors, including medullary thyroid carcinoma, in humans ^[2]. Ozempic is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 ^[2]. Other warnings include acute pancreatitis, diabetic retinopathy complications, low blood sugar when used with insulin or insulin secretagogues, acute kidney injury from volume depletion, severe gastrointestinal reactions, serious allergic reactions, gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation ^[2].

The approval announcement did not include specific A1C figures comparing the 2 mg dose with the 1 mg dose. Those numbers have not been reported.

Why it matters for patients

Ozempic is approved to improve blood sugar in adults with type 2 diabetes as an addition to diet and exercise, and its current label also covers reducing the risk of major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, and reducing the risk of worsening kidney function, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease ^[1][2].

The 2 mg pen added a fourth step for people whose blood sugar remained above target at 1 mg. Before this approval, that group had no higher dose of the Ozempic injection to move to. The approval does not change which condition Ozempic treats: it is a type 2 diabetes medicine, and a separate semaglutide product, Wegovy, is approved for weight reduction in obesity and overweight ^[1].

Whether insurers cover the 2 mg dose, and what it costs compared with lower doses, was not addressed in the approval notice ^[1].

What happens next

The 2 mg dose became part of Ozempic's approved dosing with the March 28, 2022 action ^[1]. Any later changes to the medicine's approved uses would appear in updates to its prescribing information ^[2].