FDA Approves Long-Lasting Insulin Drugs Tresiba and Ryzodeg

Disclosures

September 25, 2015

The US Food and Drug Administration (FDA) today approved two long-lasting insulin drugs from Novo Nordisk to improve blood glucose control in adults with diabetes mellitus after having rejected them in 2013 for lack of cardiovascular outcomes data.

The drugs, Tresiba and Ryzodeg 70/30, contain insulin degludec, which possesses a half-life of 25 hours and acts for least 42 hours.

Insulin degludec is the only active ingredient inTresiba. Patients inject it subcutaneously once a day. Because of the drug's extended coverage, patients do not need to take it the same time each day as with other basal insulins, leading some to call it the "Sunday-sleeping-in insulin."

Ryzodeg 70/30 contains insulin aspart, a rapid-acting agent, as well as insulin degludec. Also an injectable, Ryzodeg is taken once or twice a day with any main meal, according to a news release from Novo Nordisk.

After its initial regulatory setback 2 years ago, Novo Nordisk launched a cardiovascular trial for insulin degludec called DEVOTE and submitted interim results to the FDA earlier this year when it reapplied for approval. The manufacturer expects the trial to wrap up in the second half of 2016.

In a news release, the FDA cited clinical trials showing that both Tresiba and Ryzodeg 70/30 reduced hemoglobin A1c in patients with type 1 and type 2 diabetes who had inadequate glycemic control at the outset. The reductions resembled those achieved by previously approved long-lasting insulin drugs.

The most common adverse effects reported for the two new drugs were hypoglycemia, allergic reactions, injection-site reactions, pitting at the injection site, itching, rash, edema, and weight gain. Patients who have increased ketones in their blood or urine should not take either drug, according to the FDA.

The reputation of Tresiba was sullied last year when the German Institute for Quality and Efficiency in Healthcare reported no additional benefit of insulin degludec over existing insulins for adult patients with either type 1 or type 2 diabetes. In July, Novo Nordisk announced that it would stop distributing Tresiba in Germany by the end of September because it failed to negotiate a satisfactory price for the drug with the country's association of statutory health insurance funds.

More information about today's FDA announcement is available on the agency's website.

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