“Since 1923, Novo Nordisk has been committed to advancing insulin therapy for patients with diabetes, and we are proud to bring forward the first new basal insulin molecule to be approved by the FDA in 10 years”, explains Jesper Hiland, who is the president of Novo Nordisk in the U.S.as well as executive vice president of Novo Nordisk A/S. “Novo Nordisk is excited to launch Tresiba® in the United States in the first quarter of 2016″.
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Novo Nordisk also said it submitted a New Drug Application for Xultophy, a once-daily single-injection combination of Tresiba and the company’s diabetes drug Victoza.
Tresiba and Ryzodeg are long-acting insulins.
Todd Hobbs, chief medical officer for Novo Nordisk in North America, said diabetics using Tresiba can go as long as 42 hours between doses, compared with 18 to 24 hours for Levemir, the company’s current long-lasting insulin. In participants with type 1 and 2 diabetes who had inadequate blood sugar control at trial entry, treatment with Tresiba provided reductions in HbA1c in line with reductions achieved with other, previously approved long-acting insulin. Ryzodeg 70/30 can be administered once or twice daily with any main meal.
Researchers evaluated the safety and efficacy of Tresiba in combination with mealtime insulin in patients with type 1 diabetes in two 26-week and one 52-week active-controlled clinical trials.
Trials of almost 1,400 patients taking Ryzodeg 70/30 showed similar results.
The FDA approved the drugs with a warning that they should not be used in patients who have high levels of the chemical ketone. The most common adverse reactions associated with Tresiba and Ryzodeg in clinical trials were hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), itching, rash, edema, and weight gain.
Patients or caregivers should monitor blood glucose in all patients treated with insulin.
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As an ultra-long acting product, Tresiba is sold at a premium to other insulins, but Novo Nordisk said the company has not yet determined a USA price for the new insulin. As with any insulin, these treatments carry a risk of severe, life-threatening generalized allergy, as well.
