On 26 March 2015, Novo Nordisk announced the decision to submit the class II resubmissions of the NDAs following the completion of the interim analysis of the cardiovascular outcomes trial for insulin degludec, DEVOTE. These drugs are long-acting insulins that are only injected once or twice a day. Treatment with Tresiba led to reductions in HbA1c in line with reductions achieved with other, previously approved long-acting insulin.
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Tresiba received approval from the US Food and Drug Administration (FDA) after it appeared safe and effective in multiple trials.
The regulator also approved the company’s Ryzodeg, an injection that combines Tresiba and a fast-acting manmade form of insulin. In a “treat-to-target” study supporting the new drug application where Ryzodeg 70/30 was compared to NovoLogMix 70/30, Ryzodeg 70/30 showed equivalent reductions in HbA1c. Long-acting insulins play an essential role in the treatment of patients with type-1 diabetes and in patients with type-2 diabetes with advanced disease. Ryzodeg is a mixture of insulin degludec and insulin aspart, a rapid-acting human insulin analog.
Friday’s FDA approvals include warnings that Tresiba and Ryzodeg should not be used by patients who have high levels of the chemical ketone. The FDA concluded based on the provided data that Tresibaimproves glycemic control, achieving comparable A1C reductions (noninferiority) to FDA-approved comparators. As with all insulin regimens, patients and caregivers should carefully monitor blood glucose.
Insulin regimens should be modified cautiously and only under medical supervision.
The most common adverse reactions associated with Tresiba and Ryzodeg in clinical trials were hypoglycemia, allergic reactions, injection site reactions, injection site lipodystrophy, itching, rash, edema, and weight gain. As with any insulin, these treatments carry a risk of severe, life-threatening generalized allergy, as well.
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Novo Nordisk, the world’s largest diabetes drugs maker, separately said it expects to launch Tresiba in the United States during the first quarter of 2016.
