FDA clears Novo’s Tresiba and Ryzodeg

The U.S. Food and Drug Administration has approved two diabetes drugs from Danish drugmaker Novo Nordisk.

The second drug to receive FDA approval, Ryzodeg 70/30, which combines a long-acting insulin analog (insulin degludec) with a rapid-acting human insulin analog (insulin aspart), is also indicated for improvement of glycemic control in adults with diabetes.

“The USA market for basal insulin represents over 80 per cent of the global market for basal insulin, which underlines the importance of Tresiba”, said Soren Lontoft Hansen, senior analyst at brokerage firm Sydbank.

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 Rzyodeg provided reductions in HbA1c equivalent to reductions achieved with other, previously approved long-acting or pre-mixed insulin in patients with inadequate blood sugar control at trial entry. 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.

The efficacy and safety of Ryzodeg 70/30 were evaluated in clinical trials.

Adverse reactions to both products include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, itching, rash, edema, and weight gain.

Patients should not take either medication if they have increased ketones in their blood or urine. In “treat-to-target” studies comparing Tresiba to insulin glargine, people using Tresiba achieved similar reduction in long-term blood glucose (HbA1c), numerically greater fasting plasma glucose reduction, while using numerically lower doses of insulin in a majority of the studies. As with any insulin, these treatments carry a risk of severe, life-threatening generalized allergy, as well.

Both diabetes treatments are manufactured by Novo Nordisk.