The agent also preferred our Ryzodeg, an shot that puts together Tresiba plus a fast-acting artificial method of production of glucose.
Advertisement
The FDA said Friday that Tresiba’s efficacy and safety were evaluated in four 26-week and two 52-week active-controlled clinical trials involving 2,702 participants.
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. Tresiba is indicated for use alone, or in combination with oral antidiabetic medicines or bolus insulin, and is approved for glycemic control in adults with type 1 and type 2 diabetes. 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. 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.
Ryzodeg is a 70/30 mixture of long-acting insulin degludec and rapid-acting insulin aspart, administered once or twice daily with the main meal(s).
Neither should be used in patients who have high levels of ketones in their blood or urine. As with all insulin regimens, patients and caregivers should carefully monitor blood glucose.
Hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site, itching, rash, edema and weight gain were the most common adverse events associated with Tresiba and Ryzodeg in clinical trials.
Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin.
Advertisement
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.
