Two new insulins have gained FDA approval.

Insulin degludec (Tresiba) and insulin degludec/insulin aspart (Ryzodeg 70/30) – both manufactured by Novo Nordisk – have been shown to improve glucose control in adults with hard-to-regulate type 1 diabetes, and in patients with advanced type 2 diabetes, according to the Food and Drug Administration statement announcing the approvals on Sept. 25.

Insulin degludec is intended to be used as add-on therapy to prandial insulin or oral antidiabetic drugs. Findings from 9 randomized studies comprising almost 4,000 patients supported the approval: three in patients with type 1 disease and six in patients with type 2 disease.

Three trials comprising 1,102 patients with type 1 diabetes examined degludec in combination with prandial insulin or oral therapy. Six trials comprising 2,702 patients with type 2 diabetes also examined the drug in combination with prandial insulin or as an add-on to oral therapy. In all of these studies, degludec was associated with reductions in HbA1c.

The combination of the long-acting insulin degludec and rapid-acting insulin aspart was evaluated in five studies – one with 362 patients with type 1 diabetes and four comprising 998 patients with type 2 disease.

In the first study, the drug was used with prandial insulin. In the second group of studies, it was administered once or twice a day as the sole treatment.

Both Tresiba and Ryzodeg have been approved in Europe, Mexico, and Japan.

The most common adverse reactions associated with both drugs in clinical trials were hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, itching, rash, edema, and weight gain, according to the FDA.

In 2013, FDA refused to approve either of these drugs, despite a positive recommendation from the review committee. The agency asked for additional cardiovascular risk data, which Novo Nordisk is now acquiring with a 7,600-patient study called DEVOTE . DEVOTE is set to be completed in 2016; it is designed to generate follow-up data for 2 additional years.

In April, the company resubmitted its new drug application based on the study’s interim results, which are not publicly available.

msullivan@frontlinemedcom.com

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