FDA Approves Two New Medications for Diabetes
Tresiba and Ryzodeg approved for use in adults with type 1 and 2 diabetes mellitus
MONDAY, Sept. 28, 2015 (HealthDay News) -- Two new diabetes treatments, Tresiba (insulin degludec injection) and Ryzodeg (insulin degludec/insulin aspart injection), have been approved by the U.S. Food and Drug Administration.
Tresiba is a long-acting insulin product, the agency said in a news release. It is injected once daily and helps control blood glucose levels in patients with both type 1 and type 2 diabetes. The FDA also approved a related treatment, Ryzodeg, which combines Tresiba and another insulin.
The FDA said in its news release Friday that Tresiba's overall efficacy and safety were evaluated in numerous trials involving more than 3,700 patients with type 1 and type 2 diabetes. The results showed that reductions in HbA1c were comparable to other long-acting insulin products, the agency added.
Tresiba and Ryzodeg should not be used by diabetes patients who have high levels of ketones in their blood, and some common effects include episodes of hypoglycemia, allergic reactions, rash, itching, edema, and weight gain, the agency noted.
Both treatments are made by Novo Nordisk, based in Plainsboro, N.J.