New Diabetes Drug, Admelog (Insulin Lispro), Gets FDA OK Under 'Abbreviated' Pathway
MONDAY, Dec. 11, 2017 -- Admelog (insulin lispro), a short-acting form of insulin, has been approved by the U.S. Food and Drug Administration to treat people with either type of diabetes, for patients aged three years and older.
It's the first drug approved as a "follow-up" product based on an abbreviated new process dubbed 505(b)(2), the agency said Monday in a news release.
A new drug approved this way relies on the agency's finding that "a previously approved drug is safe and effective, or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified," the FDA said.
The abbreviated process "can reduce development costs, so products can be offered at a lower price to patients," the agency explained.
"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 though the agency's abbreviated pathways," said FDA Commissioner Dr. Scott Gottlieb.
Admelog was approved under the new process in part due to its similarity to the diabetes drug Humalog, the agency said. Admelog itself was evaluated in clinical trials involving about 1,000 people.
The most common side effects included hypoglycemia (low blood sugar), itching and rash. A less common but more serious adverse reaction could include life-threatening allergic reaction, including anaphylaxis, the FDA said.
Admelog should not be used by people with hypoglycemia, or by people who are "hypersensitive" to the drug's active ingredient insulin lispro, the agency warned. And people at risk of too much blood potassium (hyperkalemia) should be monitored carefully while taking Admelog.
Short-acting insulin products are typically given just before meals to help control blood sugar after a person eats. This type of drug is more likely to be used by a person with type 1 diabetes than a person with type 2, the agency said.
More than 30 million people in the United States have diabetes, the Centers for Disease Control and Prevention says. The chronic disease is triggered by the body's inability to produce or process the sugar-regulating hormone insulin. Complications could include heart disease, blindness, and nerve and kidney damage.
Admelog is produced by the French firm Sanofi-Aventis, whose U.S. headquarters is based in Chattanooga, Tenn.
Visit the FDA to learn more.
Posted: December 2017