The Food and Drug Administration has approved semaglutide (OZEMPIC) injections for treatment of type 2 diabetes in adults, according to a press release from Novo Nordisk.
Semaglutide is a once-weekly injection of glucagon-like peptide (GLP-1) receptor agonist that, combined with diet and exercise, can improve glycemic control in adults with type 2 diabetes. Weekly injections are administered by health care providers in a prefilled pen subcutaneously in the stomach, abdomen, thigh, or upper arm as a 0.5-mg or 1-mg formulation. It is important that all doses be administered on the same day each week, according to the OZEMPIC package insert.
“The OZEMPIC (semaglutide) approval builds on Novo Nordisk’s commitment to offering health care professionals a range of treatments that effectively addresses the complex needs of diabetes management and fits their patients’ lifestyles,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk.
Semaglutide’s approval is based on the results of a phase 3a clinical trial program involving more than 8,000 adults with type 2 diabetes who showed statistically significant reductions in their hemoglobin A1c results. In addition to the improved A1c results, patients in the trial experienced reductions in body weight. The most common adverse reactions to semaglutide were gastrointestinal issues such as nausea, vomiting, abdominal pain, and constipation, but less than 5% of patients reported these reactions.
To ensure access to semaglutide, Novo Nordisk is pricing the drug competitively with other GLP-1 receptor agonists and will offer an associated savings card program to reduce copays for insured patients, the company said. Novo Nordisk expects to launch OZEMPIC in the United States in the first quarter of 2018, and is working on contracting solutions with health insurance providers to increase patient access to the drug.
According to the Novo Nordisk statement, clinicians should not consider semaglutide as a first choice option for treating diabetes or as a substitute for insulin in patients with type 1 diabetes and diabetic ketoacidosis. Whether semaglutide can be used by people who have had pancreatitis or is safe in patients under the age of 18 years old remains to be seen.
“Type 2 diabetes is a serious condition that affects more than 28 million people in the U.S., and despite advancements in treatment, some people with type 2 diabetes do not achieve their A1c goals,” said Helena Rodbard, MD, past president of the American Association of Clinical Endocrinologists. “The approval of semaglutide offers health care professionals an important new treatment option to help adults with type 2 diabetes meet their A1c goals.”