FDA Approves New Diabetes Treatment
A new diabetes treatment was approved by the U.S. Food and Drug Administration on Friday.
Sold under the brand name Tresiba, the drug is a long-acting insulin product, the agency said in a news release. It is injected once daily and helps control blood sugar levels in people with both type 1 and type 2 diabetes.
The FDA also approved a related treatment, Ryzodeg, which combines Tresiba and another insulin. Both treatments are made by Novo Nordisk, based in Plainsboro, N.J.
In 2013, the FDA rejected the company's request for approval of Tresiba because of concerns over heart safety, the Wall Street Journal reported. At the time, the agency requested a trial looking at any possible heart risks in people using Treisba. Last March, the company resubmitted its application for Tresiba after an interim analysis of that trial, the newspaper reported.
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 diabetes. The results showed that blood-sugar reduction was comparable to other long-acting insulin products, the agency added.
"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," Dr. Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, said in the news release. "The FDA remains committed to support the development of innovative therapies for the treatment of diabetes."
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 low blood sugar, allergic reactions, rashes, itching, swelling and weight gain, the agency noted.
FDA Approves New Diabetes Treatment
A new diabetes treatment was approved by the U.S. Food and Drug Administration on Friday.
Sold under the brand name Tresiba, the drug is a long-acting insulin product, the agency said in a news release. It is injected once daily and helps control blood sugar levels in people with both type 1 and type 2 diabetes.
The FDA also approved a related treatment, Ryzodeg, which combines Tresiba and another insulin. Both treatments are made by Novo Nordisk, based in Plainsboro, N.J.
In 2013, the FDA rejected the company's request for approval of Tresiba because of concerns over heart safety, the Wall Street Journal reported. At the time, the agency requested a trial looking at any possible heart risks in people using Treisba. Last March, the company resubmitted its application for Tresiba after an interim analysis of that trial, the newspaper reported.
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 diabetes. The results showed that blood-sugar reduction was comparable to other long-acting insulin products, the agency added.
"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," Dr. Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, said in the news release. "The FDA remains committed to support the development of innovative therapies for the treatment of diabetes."
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 low blood sugar, allergic reactions, rashes, itching, swelling and weight gain, the agency noted.