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FDA OKs Levemir for tots and pregnant women

Levemir insulin approved for toddlers

Insulin detemir (Levemir) has received FDA approval for children ages 2 to 5 with type 1 diabetes. It was previously approved for people with type 1 diabetes aged 6 years through adulthood and for the treatment of type 2 diabetes in adults.

Novo Nordisk said the approval makes insulin detemir the only FDA-approved insulin analog available for children 5 and younger as basal therapy.

Underlying the approval was a trial in 82 diabetic children that compared insulin detemir with neutral protamine Hagedorn (NPH) insulin. After one year of treatment, no clinically significant change in glycated hemoglobin levels was seen with either form of insulin, and the levels remained below the target of 8.5% set by the American Diabetes Association for children younger than 6.

Also, according to Novo Nordisk, a prespecified subgroup analysis indicated that hypoglycemia episodes were less common with insulin detemir plus insulin aspart (NovoLog), a rapid-acting insulin, compared with NPH insulin plus NovoLog (mean 50.6 versus 78.3 episodes per patient-year).

Adverse events overall were slightly less common with insulin detemir, according to Novo Nordisk, affecting 69.0% of children taking it versus 77.5% of those in the NPH insulin group.

Gastroenteritis and dyspepsia were the most common severe events, seen in about equal numbers in the two treatment groups, the company said.
Like other pediatric insulin products, insulin detemir is given by injection. It already was approved for older children and adults with type 1 diabetes and for adults with type 2 diabetes.

Levemir insulin approved for use in pregnant women

The U.S. Food and Drug Administration (FDA) has just approved Levemir®, an insulin detemir [rDNA origin] injection, as the first and only basal insulin analog for Pregnancy Category B classification, which indicates that Levemir® does not pose a higher risk of harm for the unborn when used in pregnant women with diabetes. The drug is manufactured by Novo Nordisk.

Until now, the standard of care for diabetes in pregnancy has consisted of NPH, i.e. human insulin, Lois Jovanovič, MD, MACE, Chief Scientific Officer at Sansum Diabetes Research Institute in Santa Barbara, California remarked:

"It is exciting that the FDA has granted approval for this new category rating for Levemir®. For women who are pregnant, diabetes can be extremely challenging; they must be even more diligent and careful when monitoring blood sugar levels than before they were pregnant. This approval provides patients with a long-acting insulin analog option that can help them manage their blood sugar."

The insulin drug Levemir, whose generic name is detemir, has been moved from a riskier category of medications for pregnant women to a less risky category by the FDA.

Levemir was initially approved by the FDA in 2005 for use by diabetics to help control their glycemic levels. Though previously listed as a "Category C" medication, the FDA's updated drug label now lists Levemir as a "Category B" medication for pregnancy.

The FDA has five categories to classify the relative safety of taking a drug during pregnancy. Category C is the middle risk category, including drugs for which animals studies "have shown an adverse effect on the fetus" but for which "there are no adequate and well-controlled studies in humans."

Category C medications are often given to women if a caregiver determines that the potential benefits of taking the drug are enough to take the risk of the unknown. This is where Levemir had previously been listed.

It is now listed in Category B, in which animals studies "have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women." Because of medical ethics concerns, it is often difficult to adequately conduct clinical trials for medications in pregnant women.

Categories D and X include drugs which have been shown to cause birth defects, but Category C is a medium risk group.

Category A includes drugs for which "adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy" as well as later trimesters.

In a controlled clinical trial of 310 pregnant women who had type 1 diabetes, the women who took Levemir did not have children with a higher rate of birth defects.

The women who participated in the study were in their first trimester of pregnancy. Half took Levemir once or twice daily, and the other half took NPH insulin once, twice or three times a day.

There were slightly more cases of pre-eclampsia in the group that took Levemir - 10.5% compared to 7% - but women with diabetes are at a higher risk for pre-eclampsia, and these numbers were within the expected ranges. The researchers could not determine whether the higher rate of pre-eclampsia was related to Levemir.

Fewer than 5 percent of the women taking Levemir experienced side effects. The most commonly reported side effects were headache and getting a cold.

Other adverse events reported in both groups included anemia, diarrhea, urinary tract infections, gastroenteritis, upper abdominal pain and vomiting; the percentages were slightly higher for each of these in the Levemir group over the insulin group.

No difference in blood pressure rates between the two groups were reported, and an approximately similar number of miscarriages occurred in both groups (6.6 percent and 5.1 percent).
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