FDA Approves 2 Previously Rejected Diabetes Drugs

SEPTEMBER 25, 2015
Meghan Ross, Associate Editor
The FDA today approved insulin degludec injection (Tresiba) and insulin degludec/insulin aspart injection (Ryzodeg) 70/30 to improve glucose control in adults with diabetes.

The agency originally refused to approve Tresiba and Ryzodeg 2 years ago, citing concerns about the drugs’ adverse cardiovascular effects. But in April, the FDA began reviewing resubmitted regulatory applications for the treatments, which ultimately led to their approvals today.

Tresiba is a once-daily treatment administered subcutaneously at any time of day and dosed based on the individual patient’s needs. The FDA approved the long-acting insulin analog for adults with both type 1 and 2 diabetes. The drug has a duration of action of at least 42 hours.
In clinical trials, Tresiba in combination with mealtime insulin led to reductions in HbA1c similar to reductions achieved using other approved long-acting insulin, among patients with type 1 and 2 diabetes who had inadequate blood control at the beginning of the trial.

Ryzodeg 70/30 is a mixture of a rapid-acting human insulin analog and long-acting insulin analog that can help treat adults with diabetes mellitus.

In combination with mealtime insulin, Ryzodeg also provided reductions in HbA1c similar to other approved long-acting or pre-mixed insulin.

Adverse reactions to both products include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, itching, rash, edema, and weight gain. As with any insulin, these treatments carry a risk of severe, life-threatening generalized allergy, as well. 

Patients should not take either medication if they have increased ketones in their blood or urine.

Both diabetes treatments are manufactured by Novo Nordisk.

"...We believe these products offer significant benefits and important treatment options for people with type 1 and type 2 diabetes," stated Lars Rebien Sørensen, president and chief executive officer of Novo Nordisk, in a press release. "...We look forward to making Tresiba available for people in the United States.”