FDA Approvals, Highlights, and Summaries: Endocrinology

February 27, 2020

Evenity (romosozumab)

Romosozumab is a monoclonal antibody that binds with and inhibits sclerostin, a regulatory factor in bone metabolism. Sclerostin inhibition increases bone formation and, to a lesser extent, decreases bone resorption. Romosozumab is indicated for osteoporosis treatment in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture or multiple risk factors for fracture. It is also indicated for patients who have failed or are intolerant of other available osteoporosis therapy.

A boxed warning is included in the prescribing information to warn of an increased risk of major adverse cardiovascular events, including myocardial infarction, stroke, and death. Patients who have had a myocardial infarction or stroke within the past year should not receive romosozumab.

FDA approval was based on the FRAME study, which included over 7000 women who had a T score of -2.5 to -3.5 at the total hip or femoral neck. Patients were randomly assigned to receive romosozumab subcutaneous injections (210 mg) or placebo monthly for 12 months. Thereafter, patients in each group received denosumab 60 mg subcutaneously every 6 months for 12 months. Results showed that romosozumab was associated with a lower risk of vertebral fracture compared with placebo at 12 months (representing a 73% lower risk with romosozumab; P<.001). At 24 months, the rates of vertebral fractures were significantly lower in the romosozumab group compared with the placebo group after each group made the transition to denosumab (0.6% [21 of 3325 patients] in the romosozumab group vs 2.5% [84 of 3327] in the placebo group, a 75% lower risk with romosozumab; P<.001).

N Engl J Med. 2016 Oct 20;375(16):1532-1543

Additional 2019 Endocrinology approvals

Baqsimi (glucagon intranasal) is indicated for severe hypoglycemia in adults and children aged 4 years or older who have diabetes.

Gvoke (glucagon) is a ready-to-use autoinjector approved for severe hypoglycemia in adults and children aged 2 years or older.

Invokana (canagliflozin ) gained approval to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.

Farxiga (dapagliflozin) gained a new indication to reduce hospitalization risk for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors.

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