(RxWiki News) The US Food and Drug Administration (FDA) has approved a short-acting insulin product to improve blood sugar levels in those with diabetes.
The FDA reviewed Admelog through an approval process that helps lower drug development costs so new medications can be marketed at lower prices for patients. Admelog's approval was supported by past research on a similar drug: Humalog (insulin lispro). The past research helped established the safety and efficacy of the active ingredient found in Admelog.
Admelog is meant to improve blood sugar control in adults with type 2 diabetes and adults and children over 3 years old who have type 1 diabetes.
“One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives," said FDA Commissioner Dr. Scott Gottlieb in a press release. “In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe, and effective alternatives to brand name drugs approved through the agency’s abbreviated pathways.”
Diabetes is a condition in which the body does not process sugar normally. This change in function can lead to potential complications, including heart disease, nerve damage and kidney damage. Insulin products like Admelog can help control blood sugar levels and prevent more serious problems.
Admelog is a short-acting insulin and is typically administered just before meals. It can be administered in multiple ways, including just below the skin, through an insulin pump or directly into a vein. Your doctor will determine your dose of Admelog based on your unique needs.
The FDA recommended monitoring your blood sugar levels daily while taking Admelog. Also, your health care provider may monitor your potassium levels if you are at risk for hypokalemia (low amounts of potassium in the blood).
You shouldn't take Admelog if you have low blood sugar or are allergic to Admelog, insulin lispro or any of its ingredients, according to the FDA. Common side effects of Admelog included low blood sugar, itching and rash. Severe, life-threatening allergic reactions can occur.
The FDA granted Admelog's approval to Sanofi-Aventis U.S.